For many applications, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is required to publish a summary of the application once the applicant has been notified that the application has been accepted for assessment. The summary will be removed once the application is finalised.
The types of applications requiring an application summary include those for new active constituents, products and labels and applications involving variation to products and labels, where the variation involves a change in the use, supply or disposal of the product.
The summaries include details of the applications as specified in Divisions 2.1 and 2.2 of the regulations.
Please remember to follow the guidance for preparing information lists when preparing your application to avoid sensitive information being published.
For more information, please see the questions and answers.
Use the filter and links below to find and view application summaries.
Date
Application Date
Application No
Application Number
149250
Product/Active constituent Name
Application Product Name
pencycuron
Application Date
Application Number
149250
Application Product Name
pencycuron
Application details
Product name:
pencycuron
Active name:
pencycuron
Applicant Name:
GOWAN CROP PROTECTION AUSTRALIA PTY LTD
Application purpose and description of use:
Approval of pencycuron for use in agricultural chemical products.
Description of data provided:
Data no
290293
Title
Part 9 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290290
Title
Part 6 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290291
Title
Part 7 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290285
Title
Part 1 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290294
Title
Justification for use of pilot plant batches for 5-batch study
Study date
21 May 2025
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290288
Title
Part 4 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290289
Title
Part 5 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290292
Title
Part 8 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290286
Title
Part 2 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290295
Title
Pencycuron - Chemistry/Manufacturing dossier ID DC17-15391596
Study date
23 July 2025
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Data no
290287
Title
Part 3 - Analytical characterization of 5 batches of GWN-8122 technical product (Rallis India Limited plant Dahej).
Study date
April 2024
Auth party contact address
15-17 Silver Crescent WESTLEIGH Australia
Date
Application Date
Application No
Application Number
149564
Product/Active constituent Name
Application Product Name
CLETHODIM
Application Date
Application Number
149564
Application Product Name
CLETHODIM
Application details
Product name:
CLETHODIM
Active name:
CLETHODIM
Applicant Name:
Shandong Binnong Technology Co Ltd
Application purpose and description of use:
This submission is for the approval of a new source of CLETHODIM technical which will be used in
agricultural herbicide formulations.
Description of data provided:
Data no
291381
Title
2 0 Chemistry and Manufacture of Clethodim AC
Study date
15 August 2025
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291384
Title
Preliminary Analysis and Enforcement Analytical Method of Clethodim TC - Impurities Analysis Report
Study date
24 August 2022
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291387
Title
SDS of Raw Material for Clethodim TC
Study date
01 August 2025
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291390
Title
Declaration of Manufactured Batches of Clethodim
Study date
12 August 2025
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291385
Title
Preliminary Analysis and Enforcement Analytical Method of Clethodim TC - Impurities Chromatogram
Study date
24 August 2022
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291391
Title
Quality Control Data of Clethodim Technical
Study date
15 August 2022
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291388
Title
Formation of Impurities in Clethodim TC
Study date
09 March 2024
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291382
Title
Preliminary Analysis and Enforcement Analytical Method of Clethodim TC - A.I. Analysis Report
Study date
24 August 2022
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291389
Title
Declaration of Composition of Clethodim (DoC)
Study date
18 January 2025
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291383
Title
Preliminary Analysis and Enforcement Analytical Method of Clethodim TC - A.I. Chromatogram
Study date
24 August 2022
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Data no
291386
Title
Manufacturing Process and Quality control of Clethodim Technical
Study date
04 March 2024
Auth party contact address
NO. 1111 HUANGHE 11 ROAD BINZHOU CITY SHANDONG PROVINCE China
Date
Application Date
Application No
Application Number
149940
Product/Active constituent Name
Application Product Name
COBALIFE VB12 FOR SHEEP AND CATTLE
Application Date
Application Number
149940
Application Product Name
COBALIFE VB12 FOR SHEEP AND CATTLE
Application details
Product name:
COBALIFE VB12 FOR SHEEP AND CATTLE
Product number:
61466
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Update label of an approved veterinary medicine to comply with the current Vet Labelling Code.
Active constituents:
Active constituent name
85148 - Hydroxocobalamin Acetate
Description of data provided:
Data no
301474
Title
Recent developments in the detection and treatment of vitamin B12 deficiency in sheep and
cattle at pasture
cattle at pasture
Study date
2002
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
301475
Title
Nutrient Requirements of Dairy Cattle
Study date
30 Aug 2021
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
301473
Title
2025-Nov-27-61466-149440-Response to Questions
Study date
27 Nov 2025
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Data no
301476
Title
Treatment of Cobalt Deficiency in Calves
Study date
January 1981
Auth party contact address
7 Eden Park Drive MACQUARIE PARK Australia
Date
Application Date
Application No
Application Number
149189
Product/Active constituent Name
Application Product Name
Smart Garden - Smart Start Hormone Gel
Application Date
Application Number
149189
Application Product Name
Smart Garden - Smart Start Hormone Gel
Application details
Product name:
Smart Garden - Smart Start Hormone Gel
Product number:
96399
Applicant Name:
SMART GARDEN PTY LTD
Application purpose and description of use:
Registration of a 3 g/L indole-3-butyric acid (IBA) gel for promoting root growth for the propagation of soft and semi-hardwood cuttings.
Reference details:
48143 - YATES CLONEX ROOTING HORMONE GEL PURPLE
Description of data provided:
Data no
289996
Title
COA
Study date
2025
Auth party contact address
Jijiashan Industrial Park, Heshan District, Hebi City, Henan Province, china
Data no
289995
Title
Manufacturer declaration details
Study date
2025
Auth party contact address
Jijiashan Industrial Park, Heshan District, Hebi City, Henan Province, china
Date
Application Date
Application No
Application Number
149492
Product/Active constituent Name
Application Product Name
Comaster Herbicide
Application Date
Application Number
149492
Application Product Name
Comaster Herbicide
Application details
Product name:
Comaster Herbicide
Product number:
96476
Applicant Name:
Shandong Rainbow International Co Ltd
Application purpose and description of use:
Registration of a new Comaster Herbicide, 480g/L Clomazone product label for the control of certain annual broad leaf weeds in Rice, Cucurbits, Green Beans, Navy Beans, Potatoes, Poppies and Tobacco as per the Directions for Use Table and to add pack size range 1L- 1000L.
Reference details:
49604 - MAGISTER COMMAND 480 EC HERBICIDE
49604 - MAGISTER COMMAND 480 EC HERBICIDE
Active constituents:
Active constituent name
68651 - CLOMAZONE
Description of data provided:
Data no
291226
Title
Method Validation for the Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291232
Title
Packaging Specification of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291235
Title
Analytical method of Clomazone 480EC Herbicide.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291246
Title
Clomazone 480 EC Rice trial Victoria.
Study date
5 April 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291238
Title
Chromatograms of Accuracy and Precision.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291229
Title
Certificate of Analysis CoA of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291247
Title
Clomazone 480 EC Zucchini trial Queesland.
Study date
10 April 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291224
Title
Manufacturing Process of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291241
Title
Chromatograms of Solvent blank.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291230
Title
Certificate of Analysis CoA of Clomazone reference standard.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291233
Title
Certificate of analysis CoA Clomazone Technical.
Study date
22 Sep 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291244
Title
Reference Market standard label
Study date
11 Aug 2025
Auth party contact address
-
Data no
291227
Title
Accelerated storage stability of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291222
Title
Part 2- Chemistry and Manufacture
Study date
7 Aug 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291245
Title
Clomazone 480 EC Rice trial Victoria.
Study date
5 April 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291228
Title
APVMA registration certificate of Clomazone Technical.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291239
Title
Chromatograms of Clomazone content.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291242
Title
Part 8 - Crop efficacy and Safety
Study date
7 Aug 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291225
Title
Recipe information of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291236
Title
Declaration of Composition DoC of Clomazone Technical.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291243
Title
proposed draft Comaster Herbicide label
Study date
11 Aug 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291237
Title
SDS combined Proposed product and all other ingredients.
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291223
Title
Specification of Clomazone 480 EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291240
Title
Chromatograms of Linearity
Study date
8 Dec 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291231
Title
Low temperature stability report of Clomazone 480EC Herbicide.
Study date
8 December 2024
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Data no
291234
Title
Name of nominated agent letter.
Study date
26 May 2025
Auth party contact address
19th & 20th Floor Hanyu Financial Centre Building A3-4, No.7000 East Jingshi Road China
Date
Application Date
Application No
Application Number
149695
Product/Active constituent Name
Application Product Name
NO Clothes Moths Super Pheromone Traps
Application Date
Application Number
149695
Application Product Name
NO Clothes Moths Super Pheromone Traps
Application details
Product name:
NO Clothes Moths Super Pheromone Traps
Product number:
96531
Applicant Name:
AMALGAMATED HARDWARE MERCHANTS (AUSTRALIA) PTY LIMITED
Application purpose and description of use:
Registration of a 0.2 g/kg Koiginal I & Koiginal II ready to use bait formulation for attracting and trapping clothing moths and carpet moths.
Reference details:
95062 - NO Clothes Moths Pheromone Traps
Description of data provided:
Data no
291550
Title
Manufacturer's Declaration
Study date
2025
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Data no
291551
Title
Executive Summary
Study date
2025
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Date
Application Date
Application No
Application Number
149561
Product/Active constituent Name
Application Product Name
MONEPANTEL + ABAMECTIN ORAL DRENCH FOR SHEEP & CATTLE
Application Date
Application Number
149561
Application Product Name
MONEPANTEL + ABAMECTIN ORAL DRENCH FOR SHEEP & CATTLE
Application details
Product name:
MONEPANTEL + ABAMECTIN ORAL DRENCH FOR SHEEP & CATTLE
Product number:
96507
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
Registration of a 25 mg/mL monepantel and 2 mg/mL abamectin oral drench for the treatment and control of gastrointestinal roundworms in sheep and cattle.
Reference details:
69763 - ZOLVIX PLUS BROAD SPECTRUM ORAL ANTHELMINTIC FOR SHEEP AND CATTLE
Active constituents:
Active constituent name
93344 - Abamectin
Description of data provided:
Data no
290445
Title
Product specifications
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
290444
Title
Certificate of analysis
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
149562
Product/Active constituent Name
Application Product Name
Monepantel
Application Date
Application Number
149562
Application Product Name
Monepantel
Application details
Product name:
Monepantel
Active name:
Monepantel
Applicant Name:
ALLEVA ANIMAL HEALTH LTD
Application purpose and description of use:
New source of active constituent.
Description of data provided:
Data no
291289
Title
DMF3
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
291287
Title
DMF1
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
291290
Title
DMF4
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
291288
Title
DMF2
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Data no
291286
Title
Certificates of analysis
Study date
2025
Auth party contact address
1/116a Harris Rd East Tamaki New Zealand
Date
Application Date
Application No
Application Number
149577
Product/Active constituent Name
Application Product Name
C.S.S.P. PHOSPHORUS PIG POISON
Application Date
Application Number
149577
Application Product Name
C.S.S.P. PHOSPHORUS PIG POISON
Application details
Product name:
C.S.S.P. PHOSPHORUS PIG POISON
Product number:
41130
Applicant Name:
F. H. TREWEEKE PTY LTD
Application purpose and description of use:
Variation of product registration and label approval to allow use of C.S.S.P. PHOSPHORUS PIG POISON in all States and Territories.
Reference details:
61293 - PIGOUT FERAL PIG BAIT
Description of data provided:
Data no
291553
Title
CSSP APPROVED LABEL 0802
Study date
2002
Auth party contact address
44 Cooper Rd Felton Australia
Data no
291552
Title
Executive Summary
Study date
2025
Auth party contact address
44 Cooper Rd Felton Australia
Date
Application Date
Application No
Application Number
149320
Product/Active constituent Name
Application Product Name
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Application Date
Application Number
149320
Application Product Name
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Application details
Product name:
SABAKEM IMIDACLOPRID 350SC SOIL INSECTICIDE
Product number:
69122
Applicant Name:
SABAKEM PTY LTD
Application purpose and description of use:
Variation of label approval to add an additional treatment method.
Active constituents:
Active constituent name
64766 - IMIDACLOPRID
Description of data provided:
Data no
290735
Title
8.3 Scientific Argument
Study date
Dec 2024
Auth party contact address
Suite 809, Level 8, 2 Queen Street Melbourne Australia
Date
Application Date
Application No
Application Number
149525
Product/Active constituent Name
Application Product Name
SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Application Date
Application Number
149525
Application Product Name
SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Application details
Product name:
SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Product number:
96490
Applicant Name:
S.C. JOHNSON & SON PTY LTD
Application purpose and description of use:
Registration of a 9.6 g/kg indoxacarb bait (equivalent to 5 g/kg of the active S-isomer) for the control of cockroaches in household situations.
Reference details:
61513 - RAID MAX COCKROACH BAITS
Active constituents:
Active constituent name
51669 - INDOXACARB AND ITS R-ENANTIOMER (DPX-MP062) MANUFACTURING CONCENTRATE
Description of data provided:
Data no
291318
Title
Laboratory Study to Determine the Time Taken by SC Johnson A Family Company Raid Max Cockroach Baits and Raid Max Cockroach Baits to Kill American and German Cockroaches (PRC Ref. No. R24-2229)
Study date
11 July 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291312
Title
Certificate of Analysis of SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291315
Title
Safety Data Sheet - SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291321
Title
Summary Part 2 Chemistry and Manufacture
Study date
August 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291309
Title
APVMA Public Release Summary on Evaluation of the new active Indoxacarb (S-Isomer) in the product DUPONT STEWARD EC INSECTICIDE
Study date
February 2007
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291316
Title
Biosecurity Import Conditions (BICON) Permit
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291310
Title
MSDSs and specifications for constituents
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291313
Title
Stability Testing of SC JOHNSON A FAMILY COMPANY RAID MAX COCKROACH BAITS (EUR14-44-1)
Study date
February 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291322
Title
Summary Part 8 Efficacy and Safety
Study date
August 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291308
Title
Example Batch Analysis for active constituent
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291319
Title
Arena Study to Determine the Efficacy of SC Johnson A Family Company Raid Max Cockroach Baits Against the German and American Cockroach- Six Month Study (PRC Ref. No. R24-2227 p)
Study date
11 July 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291311
Title
Manufacturing Process
Study date
2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291314
Title
Method Validation for the determination of indoxacarb in SC Johnson A Family Company Raid Max Cockroach Baits (Validation Report No. ACS-VR-165-11)
Study date
11 July 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291320
Title
Laboratory Study to Determine the Secondary Kill of SC Johnson A Family Company Raid Cockroach Baits and Mortein Kill and Protect Cockroach Baits Against the German and American Cockroach (PRC Ref. No. R25-2244)
Study date
11 July 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Data no
291317
Title
Laboratory Study to Determine the Secondary Kill of SC Johnson A Family Company Raid Cockroach Baits and Mortein Kill and Protect Cockroach Baits Against the German and American Cockroach (PRC Ref. No. R24-2228)
Study date
11 July 2025
Auth party contact address
160 Epping Rd, Lane Cove NSW 2066. Australia.
Date
Application Date
Application No
Application Number
149658
Product/Active constituent Name
Application Product Name
ASHOXY OXYTETRACYCLINE 300 MG/ML LA INJECTION
Application Date
Application Number
149658
Application Product Name
ASHOXY OXYTETRACYCLINE 300 MG/ML LA INJECTION
Application details
Product name:
ASHOXY OXYTETRACYCLINE 300 MG/ML LA INJECTION
Product number:
96530
Applicant Name:
ASHISH LIFE SCIENCE PVT. LTD.
Application purpose and description of use:
Registration of a 300 mg/mL oxytetracycline (as dihydrate) injectable product for broad spectrum antibiotic treatment in cattle, sheep and pigs.
Reference details:
53087 - ALAMYCIN LA 300 OXYTETRACYCLINE INJECTABLE SOLUTION
Active constituents:
Active constituent name
93420 - Oxytetracycline dihydrate
Description of data provided:
Data no
294722
Title
Declaration
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
290712
Title
Product specifications
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Data no
290713
Title
Certificate
Study date
2025
Auth party contact address
Plot No. J-137, M.I.D.C. TARAPUR. BOISAR DIST. PALGHAR MAHARASHTRA India
Date
Application Date
Application No
Application Number
149500
Product/Active constituent Name
Application Product Name
Titan Cazone Herbicide
Application Date
Application Number
149500
Application Product Name
Titan Cazone Herbicide
Application details
Product name:
Titan Cazone Herbicide
Product number:
96478
Applicant Name:
TITAN AG PTY LTD
Application purpose and description of use:
Registration of a 400 g/L carfentrazone-ethyl EC product for the desiccation of potato crops prior to harvest.
Reference details:
88110 - TITAN CARFENTRAZONE 400EC HERBICIDE
61716 - SPOTLIGHT PLUS HERBICIDE
Active constituents:
Active constituent name
68094 - CARFENTRAZONE-ETHYL
Description of data provided:
Data no
291259
Title
Evaluation of Titan Carfentrazone 400 EC and Titan Diquat 200 for preharvest desiccation in potatoes cv. Nicola
Study date
18 June 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291260
Title
Evaluation of Titan Carfentrazone 400 EC and Titan Diquat 200 for preharvest desiccation in potatoes cv. Russet Burbank
Study date
18 June 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291261
Title
Potato Desiccation Bioequivalence
Study date
17 June 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291262
Title
Potato Desiccation Bioequivalence
Study date
17 June 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291263
Title
Potato Des ??? Carfentrazone ??? Bioequivalence to Spotlight Plus Single Application
Study date
8 July 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291264
Title
Potato Des ??? Carfentrazone ??? Bioequivalence to Spotlight Plus Split Application
Study date
8 July 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291266
Title
Titan Cazone Efficacy and Safety Module 8.2
Study date
7 August 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Data no
291265
Title
Titan Cazone Herbicide draft label
Study date
7 August 2025
Auth party contact address
15/16 PRINCES STREET NEWPORT Australia
Date
Application Date
Application No
Application Number
149551
Product/Active constituent Name
Application Product Name
TapOut Surfactant
Application Date
Application Number
149551
Application Product Name
TapOut Surfactant
Application details
Product name:
TapOut Surfactant
Product number:
96500
Applicant Name:
CROP CULTURE PTY LTD
Application purpose and description of use:
Registration of TapOut Surfactant (904 g/L DI-1-P-MENTHENE), non-aqueous concentrate formulation, a sticking-spreader agent designed to control the life of pesticides.
Reference details:
52216 - MILLER NU-FILM-P NON-IONIC STICKER-SPREADER
61397 - MILLER NU-FILM-17 NON IONIC EXTENDER-STICKER-SPREADER
66601 - CAMPBELL FILMSTAR-21 NON-IONIC EXTENDER, STICKER AND SPREADER
83108 - Brandt Tarp Extender Sticker Spreader
88028 - Pro-Film 904 Non-Ionic Extender-Sticker-Spreader
Date
Application Date
Application No
Application Number
149449
Product/Active constituent Name
Application Product Name
KUNKOP INSECTICIDE
Application Date
Application Number
149449
Application Product Name
KUNKOP INSECTICIDE
Application details
Product name:
KUNKOP INSECTICIDE
Product number:
96475
Applicant Name:
UPL AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a 240 g/L Spinosad, aqueous suspension concentrates for use in fruit, herbs, ornamentals, vegetables and forestry (Eucalyptus spp. and Tea Tree) for the control of certain insect pests as specified in the Directions for Use.
Reference details:
88118 - Entrust Organic Qalcova Active Insecticide
Active constituents:
Active constituent name
94741 - SPINOSAD
Description of data provided:
Data no
291149
Title
SPINO200_Part 2 Chemistry & Manufacturing
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291163
Title
Efficacy of UPL Spinosad formulations for control of western flower thrips (Frankliniella occidentalis) in capsicum cv. Remy, Angle Vale, South Australia, 2022/23
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291155
Title
Persistent foaming of Spinosad 240 g/L SC
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291152
Title
Accelerated storage stability and corrosion characteristics of Spinosad 240 g/L SC
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291169
Title
To test the efficacy of UPL formulations for bioequivalence to Entrust 240,Toolamba, Victoria, 2023
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291166
Title
To test the efficacy of UPL Spinosad for bioequivalence to Entrust 240 aversham, Western Australia, 2024
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291170
Title
Evaluation of the bioequivalence of UPL Spinosad 240 with Entrust for the control of citrus leaf miner in lime
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291161
Title
Efficacy of UPL Spinosad formulations for control of diamondback moth (Plutella xylostella) in brussels sprouts cv. Trimstar
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291167
Title
To test the efficacy of UPL formulations for bioequivalence to Entrust 240, Nashdale, New South Wales, 2023
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291150
Title
Document J
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291164
Title
Evaluation of bioequivalence of UPL Spinosad formulations and Entrust 240 for the control of Heliothis in lettuce Clifton Queensland Australia 2023/2024
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291158
Title
To evaluate the efficacy and crop safety of UPL Spinosad 240 for bioequivalence to Entrust Organic
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291165
Title
Evaluation of the bioequivalence of UPL Spinosad formulations with Entrust for the control of Lepidopteran pests in sweet corn
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291153
Title
Stability of Spinosad 240 g/L SC at low temperature
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291159
Title
Evaluation of the bioequivalence of UPL Spinosad with Entrust for the control Lepidoptera pests in broccoli, Clifton Queensland 2003
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291162
Title
Comparison of UPL Spinosad 240 SC and 480 SC with Entrust 240 SC and Success Neo 120 SC for the control of diamondback moth (Plutella xylostella) in Chinese cabbage (Brassica rapa pekinensis) cv. Matilda. Wanneroo, Western Australia, 2022
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291156
Title
Spinosad technical COA
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291151
Title
Chemical composition, Product Specification and Manufacturing process
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291157
Title
Part 8 240 Spinosad_KUNKOP INSECTICIDE
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291171
Title
KUNKOP INSECTICIDE label
Study date
2025
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291168
Title
To test the efficacy of UPL Spinosad formulations against Entrust 240 against Cherry slug in Stone Fruit Echunga, South Australia, 2022
Study date
2022
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291154
Title
Validation of Analytical method for determination of active ingredient content of Spinosad 240 g/L SC
Study date
2024
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Data no
291160
Title
To test the efficacy of UPL formulations for the bioequivalence to Entrust 240, Mount Barker, Sout Australia, Australia
Study date
2023
Auth party contact address
Level 3, 70 Hindmarsh Square ADELAIDE Australia
Date
Application Date
Application No
Application Number
149649
Product/Active constituent Name
Application Product Name
NO Pantry Moths Pheromone Traps Citrus
Application Date
Application Number
149649
Application Product Name
NO Pantry Moths Pheromone Traps Citrus
Application details
Product name:
NO Pantry Moths Pheromone Traps Citrus
Product number:
96525
Applicant Name:
AMALGAMATED HARDWARE MERCHANTS (AUSTRALIA) PTY LIMITED
Application purpose and description of use:
Registration of a 4.9 g/kg (Z,E)-9,12-TETRADECADIEN-1-YL ACETATE ready to use bait formulation to attract and trap pantry moths.
Reference details:
95054 - NO Pantry Moths Pheromone Traps
Description of data provided:
Data no
291258
Title
Executive Summary
Study date
2025
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Data no
291257
Title
Manufacturer's Declaration
Study date
2025
Auth party contact address
Unit 1, 169 Given Terrace Paddington Australia
Date
Application Date
Application No
Application Number
149527
Product/Active constituent Name
Application Product Name
XtendiMax 2 Herbicide with VapourGrip Technology
Application Date
Application Number
149527
Application Product Name
XtendiMax 2 Herbicide with VapourGrip Technology
Application details
Product name:
XtendiMax 2 Herbicide with VapourGrip Technology
Product number:
88630
Applicant Name:
MONSANTO AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of label approval to add a tank mix
Reference details:
93058 - VapourGrip Xtra Agent
94751 - Roundup UltraMax Herbicide with Plantshield
Active constituents:
Active constituent name
52040 - DICAMBA
Active constituent name
85321 - Dicamba
Active constituent name
44512 - DICAMBA
Description of data provided:
Data no
291327
Title
Bridging Statement. M-882595-01-1
Study date
2025-07-22
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291328
Title
Efficacy and safety module. M-883389-01-1
Study date
2025-08-11
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291326
Title
Letter of consent to access protected data and information
Study date
2025-08-04
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date
Application Date
Application No
Application Number
149524
Product/Active constituent Name
Application Product Name
Solectus 60 mg/mL Injection for Cattle
Application Date
Application Number
149524
Application Product Name
Solectus 60 mg/mL Injection for Cattle
Application details
Product name:
Solectus 60 mg/mL Injection for Cattle
Product number:
96489
Applicant Name:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Application purpose and description of use:
Registration of an injectable solution containing 60 mg/mL umifoxolaner for use as an ectoparasiticide in cattle, in conjunction with approval of umifoxolaner.
Description of data provided:
Data no
290084
Title
ML-3,032,878: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS AND ACTIVATED SLUDGE SOLIDS- raw data
Study date
24/02/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290061
Title
ML-3,032,878: AEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS - raw data files
Study date
19/07/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290038
Title
ML-3,032,878: A 52-week oral dietary toxicity study in Sprague Dawley Rats
Study date
21/09/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290101
Title
Determination of Developmental Toxicity to the Dipteran Dung Fly - raw data files
Study date
27/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290053
Title
Executive summary - Environment
Study date
29/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290090
Title
ML-3,032,878 Acute Toxicity to Water Fleas - raw data files
Study date
20/12/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290007
Title
Justification of the Specifications for the Drug Product
Study date
18 Apr 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290044
Title
PR&D 04284 ML-3,032,878: An oral (gavage) prenatal developmental toxicity study in Sprague Dawley rats
Study date
01/1/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289998
Title
Solectus 60 mg/mL Injection for Cattle Part 2 Chemistry and Manufacture Summary
Study date
8 August 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301113
Title
2024-4414 field efficacy trial
Study date
01/12/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301119
Title
2022-2003 injection site tissue residues
Study date
01/08/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290001
Title
Certificates of Analysis for Excipients
Study date
16 Dec 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290024
Title
2019247 A comparative study of [14C]- ML-3,032,878 following repeated oral (gavage) administration to rats
Study date
07/05/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301099
Title
2022-1909 dose determination
Study date
01/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290093
Title
ML-3,032,878: AN AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL
Study date
01/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301122
Title
Part 8 efficacy and safety executive summary
Study date
28/01/2026
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290018
Title
Certificates of Analysis for the Container Closure Components
Study date
13 May 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290030
Title
2023-2878 Local lymph node assay in mice final formulation
Study date
01/11/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301093
Title
PR&D 0358501 dose determination
Study date
01/07/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290067
Title
ML-3,032,878: TRANSFORMATION IN CATTLE MANURE PILOT STUDY - raw data files
Study date
02/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290073
Title
ML-3,032,878: Aerobic Transformation in Soils
Study date
06/07/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290081
Title
ML-3,032,878 - Determining the Water Solubility - raw data files
Study date
23/04/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301110
Title
2022-1908 field efficacy trial
Study date
01/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290010
Title
Stability Summary and Conclusions
Study date
19 May 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290064
Title
ML-3,032,878: ANAEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS - raw data files
Study date
24/08/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290087
Title
ML-3,032,878 - Acute Toxicity Test with Bluegill Sunfish,
Study date
11/06/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290041
Title
PR&D 04286 ML-3,032,878: An oral (gavage) two-generation reproductive toxicity study in Sprague Dawley Rats
Study date
11/10/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290104
Title
Reference Standards for Drug Product
Study date
04 Mar 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290004
Title
Description of the Manufacturing Process and Process Controls - Umifoxolaner 60 mg/mL Solution
Study date
17 Apr 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290050
Title
2024-3935 Determination of Minimal Inhibitory Concentrations (MICs) for Umifoxolaner and open chain metabolite of Umifoxolaner
Study date
23/12/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301116
Title
2021-1441 target animal safety study
Study date
01/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290047
Title
PR&D 03677 ML-3,032,878 In vitro mammalian cell micronucleus assay in TK6 cells
Study date
31/1/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290070
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges - pilot
Study date
28/09/2016
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301102
Title
2020083 field efficacy trial
Study date
01/08/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301082
Title
PR&D 04027 a comparative metabolism study
Study date
01/12/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290021
Title
PR&D 04027 A comparative metabolism study following repeated oral (gavage) administration to Beagle dogs
Study date
12/11/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290027
Title
PR&D 03698 ML-3,032,878: EXPLORATORY IN VITRO STUDY TO ASSESS TERATOGENIC POTENTIAL IN ZEBRAFISH EMBRYO CULTURE
Study date
24/08/2016
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301090
Title
Current review of isoxazoline ectoparasiticides used in veterinary medicine.
Study date
2022
Auth party contact address
-
Data no
301096
Title
PR&D 0407901 dose determination
Study date
01/12/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290036
Title
PR&D 0371201 ML-3,032,878: a 90 day oral toxicity study in Sprague Dawley Rats
Study date
20/06/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301111
Title
2024-4412 field efficacy trial
Study date
01/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290059
Title
Determination of the concent of active ingredient
Study date
29/04/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301088
Title
The novel isoxazoline ectoparasiticide fluralaner: Selective inhibition of arthropod g-aminobutyric acid- and L-glutamate-gated chloride channels and insecticidal/acaricidal activity
Study date
2014
Auth party contact address
-
Data no
290082
Title
ML-3,032,878 - valiation of the analytical method for the degtermination of a test article in aqueous solutions
Study date
17/02/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290105
Title
User Risk Assessment
Study date
8/08/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290088
Title
ML-3,032,878 - Acute Toxicity Test with Bluegill Sunfish -raw data files
Study date
11/06/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290013
Title
Stability Studies - Stress Stability Studies for the Drug Product - Temperature Cycling
Study date
17 Jul 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290042
Title
PR&D 0383501 ML-3,032,878: An oral (gavage) dose range finding study on embryo/fetal development in Sprague Dawley rats
Study date
18/03/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301105
Title
2021-1726 field efficacy trial
Study date
01/09/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301117
Title
2022-1915 target animal safety study
Study date
01/08/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290005
Title
Justification of Controls at Critical Steps
Study date
25 Mar 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290099
Title
ML-3,032,878: Determination of the Reproduction Toxicity to the Dung Beetle - raw data files
Study date
26/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301097
Title
2020002 dose determination
Study date
01/06/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290065
Title
ML-3,032,878: PILOT ANAEROBIC TRANSFORMATION STUDY IN AQUATIC SEDIMENT SYSTEMS
Study date
24/08/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290079
Title
ML-3,032,878: Chronic Toxicity to Collembola - pilot
Study date
02/11/2016
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290022
Title
PR&D 0390801 Metabolite profiling of ML-3,032,878 in H REL Rat, Mouse, Dog, Cattle and Sheep Hepatocytes Co-cultures
Study date
27/02/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301091
Title
The antiparasitic isoxazoline A1443 is a potent blocker of insect ligand-gated chloride channels
Study date
2010
Auth party contact address
-
Data no
301085
Title
2022-2004 A study to determine the PK profile of ML-878 in cattle
Study date
10/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290033
Title
PR&D 03604 ML-3,032,878: 28-day oral (dietary) toxicity study in Sprague Dawley Rats
Study date
25/04/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290039
Title
PAA 117847
Study date
12/04/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301108
Title
2024-4347 field efficacy trial
Study date
01/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290016
Title
Validation of Analytical Procedures for the Drug Product
Study date
16 Oct 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290085
Title
ML-3,032,878: developmental toxicity to the dipteran dung fly
Study date
03/11/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290062
Title
ML-3,032,878 - Validation of the Analytical Method for the Determination of a Test Article in Sediment
Study date
12/02/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290102
Title
Pharmaceutical Development - Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
15 Jul 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290056
Title
ML-3,032,878 - Purity Determination
Study date
07/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290045
Title
PR&D 04285 ML-3,032,878: An oral (gavage) prenatal developmental toxicity study in New Zealand white rabbits
Study date
19/10/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301114
Title
2023-3027 field efficacy trial
Study date
01/03/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289999
Title
Certificate of GMP Compliance of a Manufacturer
Study date
15/06/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290002
Title
Specifications for Excipients
Study date
01/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290096
Title
ML-3,032,878 - 72-Hour Toxicity Test with the Freshwater Green Alga
Study date
05/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301094
Title
PR&D 0378701 dose determination
Study date
01/02/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290019
Title
Executive summary - health
Study date
29/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290068
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges
Study date
03/03/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290076
Title
ML-3,032,878: Acute Toxicity to Earthworms
Study date
27/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290025
Title
PR&D 0390901 Plasma protein binding of ML-3,032,878 in cattle, sheep, dog, rat and mouse plasma
Study date
02/03/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301086
Title
2022-2004 bioanalytical plasma assays
Study date
10/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301109
Title
2022-1906 field efficacy trial
Study date
01/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290057
Title
ML-3,032,878 - determining the partitioning coefficient
Study date
02/02/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290063
Title
ML-3,032,878: ANAEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS
Study date
24/08/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290034
Title
PR&D 03713 ML-3,032,878: An escalating-dose phase and 7-day repeated-dose phase study by oral capsule in Beagle dogs
Study date
13/10/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290040
Title
PR&D 0392501 ML-3,032,878: An oral (gavage) range-finding reproductive toxicity study in Sprague Dawley Rats
Study date
19/12/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290011
Title
Stability Data - Accelerated and Long-Term Stability Studies for the Drug Product
Study date
19 May 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290103
Title
Packaging Procedure - Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
25 Mar 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290051
Title
Establishment of acute reference dose
Study date
19/03/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290097
Title
ML-3,032,878 - 72-Hour Toxicity Test with the Freshwater Green Alga - raw data files
Study date
05/10/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290000
Title
Batch Formula -Umifoxolaner 60 mg/mL Solution for Injection for Cattle
Study date
17 Apr 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290048
Title
PR&D 03748 ML-3,032,878: In vivo mammalian erythrocyte micronucleus assay in mice
Study date
14/02/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290071
Title
ML-3,032,878 Determination of the Abiotic Degradation by Hydrolysis
Study date
13/07/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301103
Title
2020084 field efficacy trial
Study date
01/11/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290077
Title
ML-3,032,878: Chronic Toxicity to Collembola
Study date
11/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290020
Title
PR&D 04026 A comparative metabolism study following repeated oral (gavage) administration to rats
Study date
01/12/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301083
Title
PR&D 0390601 probe radioresidue metabolism study
Study date
13/11/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290028
Title
2023-2790 Eye irritation test and BCOP final formulation
Study date
07/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301089
Title
Discovery and mode of action of afoxolaner, a new isoxazoline parasiticide for dogs.
Study date
2014
Auth party contact address
-
Data no
290060
Title
ML-3,032,878: AEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS
Study date
19/07/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290083
Title
ML-3,032,878: ADSORPTION/DESORPTION CHARACTERISTICS IN REPRESENTATIVE SOILS AND ACTIVATED SLUDGE SOLIDS
Study date
24/02/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301112
Title
2024-4413 field efficacy trial
Study date
01/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290014
Title
Stability Data - In-Use Stability Studies for the Drug Product
Study date
07 Mar 2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290037
Title
PR&D 0378601 ML-3,032,878: a 90 day oral (capsule) toxicity study in Beagle dogs
Study date
29/01/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290054
Title
PAA advice 144405
Study date
24/07/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301106
Title
2024-4345 field efficacy trial
Study date
01/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290008
Title
Batch Analyses for the Drug Product
Study date
23 Aug 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290091
Title
ML-3,032,878 Full Life-Cycle Toxicity Test with Water Fleas
Study date
09/01/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301120
Title
2022-2362 reproductive safety study
Study date
01/01/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
289997
Title
Overall executive summary - Solectus
Study date
29/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290100
Title
Determination of Developmental Toxicity to the Dipteran Dung Fly
Study date
27/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301100
Title
2023-3025 dose confirmation study
Study date
01/12/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290094
Title
ML-3,032,878: AN AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL - raw data files
Study date
01/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290017
Title
Specifications for the Container Closure Components
Study date
13 Mar 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290031
Title
PR&D 03603 ML-3,032,878: a 7-day oral gavage toxicity study in Sprague Dawley Rats
Study date
18/07/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290080
Title
ML-3,032,878 - Determining the Water Solubility
Study date
23/04/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301092
Title
Pre-application assistance 132624 written advice
Study date
2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290074
Title
ML-3,032,878: Chronic Toxicity and Reproduction Test Exposing the Earthworm,
Study date
24/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290009
Title
Certifcate of Analysis for the Drug Product
Study date
07 May 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290015
Title
Analytical Procedures for the Drug Product
Study date
16 Apr 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290086
Title
ML-3,032,878: developmental toxicity to the dipteran dung fly - raw data files
Study date
03/11/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301107
Title
2024-4346
Study date
01/11/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290055
Title
Environment risk assessment
Study date
16/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290092
Title
ML-3,032,878 Full Life-Cycle Toxicity Test with Water Fleas - raw data files
Study date
09/01/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290003
Title
Excipients of Human or Animal Origin
Study date
21 Mar 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290046
Title
PR&D 03747 ML-3,032,878 bacterial reverse mutation assay
Study date
03/01/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290049
Title
Proposal of Acceptable Daily Intake
Study date
31/10/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301115
Title
PR&D 0373901 target animal safety
Study date
01/06/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290095
Title
A NON-GLP PILOT AQUEOUS EXPOSURE BIOACCUMULATION TEST WITH THE BLUEGILL
Study date
16/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301101
Title
PR&D 0391601 dose confirmation
Study date
01/07/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301081
Title
PRD 04026 a comparative metabolism study
Study date
01/12/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290032
Title
PR&D 03708 ML-3,032,878: A 7-day oral (dietary) palatability study in Sprague Dawley Rats
Study date
04/08/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301095
Title
PR&D 04008 dose determination
Study date
01/04/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290069
Title
ML-3,032,878 - Toxicity Test with Sediment-Dwelling Midges - raw data files
Study date
23/08/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290075
Title
ML-3,032,878: Chronic Toxicity and Reproduction Test Exposing the Earthworm, - raw data files
Study date
24/01/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290026
Title
2022-2004 A Study to Determine the Pharmacokinetic Profile of ML-3,032,878 in Plasma of Cattle When Administered Once as a Single Intravenous dose (0.6 mg/kg body weight) or a Single Subcutaneous Dose
Study date
17/06/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301087
Title
PR&D 0357001 - PK, residues and excreta or ML-3,032,878
Study date
19/10/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290058
Title
Pivotal Radio-Residue Metabolism Study
Study date
10/01/2022
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290035
Title
PR&D 03714 ML-3,032,878: a 28 day repeated-dose study by oral capsule in Beagle dogs
Study date
19/12/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290012
Title
Stability Data - Stress Stability Studies for the Drug Product - Photostability
Study date
17 Jul 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290089
Title
ML-3,032,878 Acute Toxicity to Water Fleas
Study date
20/12/2017
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301118
Title
2022-1916 target aniaml safety
Study date
01/04/2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290006
Title
Specifications for the Drug Product
Study date
17 Apr 2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290043
Title
PR&D 03836 ML-3,032,878: An oral (gavage) tolerability and range-finding study on Embryo/fetal development in rabbits
Study date
18/03/2019
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290052
Title
Safety data sheets
Study date
2024
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290098
Title
ML-3,032,878: Determination of the Reproduction Toxicity to the Dung Beetle
Study date
26/06/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290072
Title
ML-3,032,878 determination of melting point
Study date
28/11/2018
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301098
Title
PR&D 0429301 dose determination
Study date
01/06/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301121
Title
2024-4152 reproductive safety study
Study date
01/05/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301104
Title
2021-1609 field efficacy trial
Study date
01/09/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290066
Title
ML-3,032,878: TRANSFORMATION IN CATTLE MANURE PILOT STUDY
Study date
02/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290078
Title
ML-3,032,878: Chronic Toxicity to Collembola - raw data files
Study date
11/07/2025
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290029
Title
2023-2791 Epiderm skin irritation test final formulation
Study date
11/09/2023
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
301084
Title
PR&D 0390801 metabolite profiling
Study date
27/02/2020
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Data no
290023
Title
2021-1122 ML-3,032,878: A 28 day pharmacokinetic study of ML-3,032,878 by intravenous injection and oral gavage in Sprague Dawley Rats
Study date
05/11/2021
Auth party contact address
Level 1 78 Waterloo Road NORTH RYDE Australia
Date
Application Date
Application No
Application Number
149526
Product/Active constituent Name
Application Product Name
VapourGrip Xtra Agent
Application Date
Application Number
149526
Application Product Name
VapourGrip Xtra Agent
Application details
Product name:
VapourGrip Xtra Agent
Product number:
93058
Applicant Name:
MONSANTO AUSTRALIA PTY LTD
Application purpose and description of use:
Variation of label approval to add a tank mix
Reference details:
94751 - Roundup UltraMax Herbicide with Plantshield
Active constituents:
Active constituent name
60575 - ACETIC ACID
Active constituent name
59979 - POTASSIUM HYDROXIDE
Description of data provided:
Data no
291324
Title
Bridging Statement. M-882595-01-1
Study date
2025-07-22
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291325
Title
Efficacy and safety module. M-883389-01-1
Study date
2025-08-11
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Data no
291323
Title
Letter of consent to access protected data and information
Study date
2025-08-04
Auth party contact address
Level 4, 109 Burwood Road Hawthorn Australia
Date
Application Date
Application No
Application Number
149529
Product/Active constituent Name
Application Product Name
Metham-sodium
Application Date
Application Number
149529
Application Product Name
Metham-sodium
Application details
Product name:
Metham-sodium
Active name:
Metham-sodium
Applicant Name:
Zhejiang Dapeng Pharmaceutical Co.,Ltd.
Application purpose and description of use:
Approval of metham-sodium manufacturing concentrate for use in agricultural chemical products.
Description of data provided:
Data no
291329
Title
Chemistry and Manufacture
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291332
Title
Declaration of Composition (DoC) of Metham-sodium
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291333
Title
Certificate of Analysis (COA) and Statement of Batch Size of Metham-sodium
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291330
Title
Synthesis and Impurities of Metham-sodium Technical
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291331
Title
Qualitative and Quantitative Profile of the test substance Metham-sodium (Five Batch Analysis)
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China
Data no
291334
Title
Metham-sodium SAFETY DATA SHEET
Study date
2025
Auth party contact address
Chemical substance base linhai block Linhai Taizhou city China