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
150010
Product/Active constituent Name
Application Product Name
4 Farmers Paraffinic Oil Insecticide
Application Date
Application Number
150010
Application Product Name
4 Farmers Paraffinic Oil Insecticide
Application details
Product name:
4 Farmers Paraffinic Oil Insecticide
Product number:
96607
Applicant Name:
4 FARMERS AUSTRALIA PTY LTD
Application purpose and description of use:
Registration of a Paraffinic Oil 81g/L as EC formulation product for use an Insecticide.
Reference details:
54179 - SACOA BIOPEST PARAFFINIC OIL
Description of data provided:
Data no
293178
Title
4 Farmers Paraffinic Oil--Chemistry and Manufacture
Study date
21/07/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Data no
293179
Title
4 Farmers Paraffinic Oil--Stability
Study date
21/07/2025
Auth party contact address
35a MCDOWELL STREET WELSHPOOL Australia
Date
Application Date
Application No
Application Number
150118
Product/Active constituent Name
Application Product Name
Quantum Butroxydim 250 WG Herbicide
Application Date
Application Number
150118
Application Product Name
Quantum Butroxydim 250 WG Herbicide
Application details
Product name:
Quantum Butroxydim 250 WG Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 250 g/kg BUTROXYDIM, water dispersible granule for the control of certain grasses in a range of broadacre crops as per the directions for use.
Date
Application Date
Application No
Application Number
150119
Product/Active constituent Name
Application Product Name
Quantum Paraquat 360 SL Herbicide
Application Date
Application Number
150119
Application Product Name
Quantum Paraquat 360 SL Herbicide
Application details
Product name:
Quantum Paraquat 360 SL Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
This application by Quantum Agrosciences Holdings Pty Ltd is for registration of a 360g/L Paraquat Soluble Concentrate (SL) product for the control of a wide range of grasses and broadleaf weeds. This product is to be named "Quantum Paraquat 360 SL Herbicide".
Date
Application Date
Application No
Application Number
150120
Product/Active constituent Name
Application Product Name
Quantum Captan 900 WG Fungicide
Application Date
Application Number
150120
Application Product Name
Quantum Captan 900 WG Fungicide
Application details
Product name:
Quantum Captan 900 WG Fungicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
This application by Quantum Agrosciences Holdings Pty Ltd is for registration of a 900g/Kg Captan Water-dispersible granules (WG) product for the control of certain diseases in almonds, a range of fruit crops, turf & ornamentals. This product is to be named "Quantum Captan 900 WG Fungicide".
Date
Application Date
Application No
Application Number
150121
Product/Active constituent Name
Application Product Name
Quantum Simazine 500 SC Herbicide
Application Date
Application Number
150121
Application Product Name
Quantum Simazine 500 SC Herbicide
Application details
Product name:
Quantum Simazine 500 SC Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
This application by Quantum Agrosciences Holdings Pty Ltd is for registration of a 500g/L Simazine Suspension
Concentrate (SC) product for selective annual weed control of weeds in lupins, orchards, vineyards, faba beans, chickpeas, non-agricultural situations, T-T canola, and other crops. This product is to be named "Quantum Simazine 500 SC Herbicide".
Date
Application Date
Application No
Application Number
149976
Product/Active constituent Name
Application Product Name
BAYTRIL OTIC ANTIBACTERIAL DROPS
Application Date
Application Number
149976
Application Product Name
BAYTRIL OTIC ANTIBACTERIAL DROPS
Application details
Product name:
BAYTRIL OTIC ANTIBACTERIAL DROPS
Product number:
51924
Applicant Name:
ELANCO AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of product label approval to align with the current VLC.
Active constituents:
Active constituent name
55105 - ENROFLOXACIN
Active constituent name
56281 - SILVER SULFADIAZINE
Date
Application Date
Application No
Application Number
150138
Product/Active constituent Name
Application Product Name
Trazocalm 50mg
Application Date
Application Number
150138
Application Product Name
Trazocalm 50mg
Application details
Product name:
Trazocalm 50mg
Product number:
96630
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a range of a trazodone hydrochloride tablet for dogs, in conjunction with approval of trazodone
hydrochloride.
Description of data provided:
Data no
291901
Title
Item 27 Trazocalm - Executive Summary
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application Date
Application No
Application Number
150135
Product/Active constituent Name
Application Product Name
Trazodone Hydrochloride
Application Date
Application Number
150135
Application Product Name
Trazodone Hydrochloride
Application details
Product name:
Trazodone Hydrochloride
Product number:
96627
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a range of a trazodone hydrochloride tablet for dogs, in conjunction with approval of trazodone hydrochloride.
Description of data provided:
Data no
291862
Title
Transfer Method
Study date
2018
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291861
Title
API Batch Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291865
Title
Trazodone Hydrochloride Manufacturing Steps
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291866
Title
API DMF Open Section a
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291867
Title
API DMF Open Section b
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291868
Title
API DMF Open Section c
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291869
Title
API DMF Open Section d
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291870
Title
API DMF Open Section e
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291871
Title
API DMF Open Section f
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291872
Title
API DMF Open Section g
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291873
Title
API DMF Open Section h
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291874
Title
API DMF Open Section i1
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291875
Title
API DMF Open Section i2
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291876
Title
API DMF Open Section i3
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291877
Title
API DMF Open Section j
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291878
Title
API DMF Open Section k
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291879
Title
API DMF Open Section l
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291880
Title
API DMF Open Section m
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291881
Title
API DMF Open Section n
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291882
Title
API DMF Open Section o
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291883
Title
API DMF Open Section p
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291884
Title
API DMF Restricted Section.
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291885
Title
Brief Manufacturing Process
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291886
Title
Reaction Scheme
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291887
Title
Manufacturing Process Flow Sheet
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291888
Title
Detailed Description of Manufacturing Process
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291889
Title
Process Controls
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291890
Title
Reprocessing & Reworking
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291891
Title
Description of Manufacturing Process of Key Raw Materials
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291892
Title
List of Starting Materials, Raw Materials, Solvents, Reagents and Catalysts used in the Manufacture
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291893
Title
Detail Specifications and Testing Procedures for Raw Materials, Starting Materials, Solvents and Catalysts used in the Manufacture
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291894
Title
Control of Critical Steps
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291895
Title
List of Intermediates
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291896
Title
Characterization of Intermediates
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291897
Title
Detail Specifications and Analytical Reports for Intermediates
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291898
Title
Process Validation and Evaluation
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291899
Title
Manufacturing Process Development
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293193
Title
Certificate of Analysis of Starting Materials, Raw Materials, Solvents, Reagents and Catalysts used in the Manufacture
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293194
Title
Manufacturers
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291863
Title
Trazodone Hydrochloride Monograph USP
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291864
Title
Trazodone Hydrochloride Monograph BP
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application Date
Application No
Application Number
150136
Product/Active constituent Name
Application Product Name
Trazocalm 150mg
Application Date
Application Number
150136
Application Product Name
Trazocalm 150mg
Application details
Product name:
Trazocalm 150mg
Product number:
96628
Applicant Name:
INVETRO PTY LTD
Application purpose and description of use:
Registration of a range of a trazodone hydrochloride tablet for dogs, in conjunction with approval of trazodone hydrochloride.
Description of data provided:
Data no
291807
Title
Finished Product Analytical Method Transfer Assay
Study date
2013
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291808
Title
Finished Product Analytical Method Transfer Related Substance
Study date
2013
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291809
Title
Finished Product Analytical Method Transfer Dissolution
Study date
2013
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291802
Title
Finished Product Standard Test Procedures 50mg
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291803
Title
Finished Product Standard Test Procedures 100mg
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291804
Title
Finished Product Standard Test Procedures 150mg
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291829
Title
Method Validation a
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291830
Title
Method Validation b
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291831
Title
Method Validation c
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291832
Title
Method Validation d
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291833
Title
Method Validation e
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291793
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291794
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291795
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291796
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291797
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291798
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291799
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291800
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291801
Title
Finished Product Certificates of Analysis
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291834
Title
Method Validation f
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291810
Title
Process Validation Protocol
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291811
Title
Process Validation Report
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291812
Title
Excipient Certificates of Analysis a
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291813
Title
Excipient Certificates of Analysis b
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291814
Title
Excipient Certificates of Analysis c
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291815
Title
Excipient Certificates of Analysis d
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291816
Title
Excipient Certificates of Analysis e
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291817
Title
Excipient Certificates of Analysis f
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291818
Title
Excipient Certificates of Analysis g
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291819
Title
Excipient Certificates of Analysis h
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291820
Title
Excipient Raw Material Specifications i
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291821
Title
Excipient Raw Material Specifications j
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291822
Title
Excipient Raw Material Specifications k
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291823
Title
Excipient Raw Material Specifications l
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291824
Title
Excipient Raw Material Specifications m
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291825
Title
Excipient Raw Material Specifications n
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291826
Title
Excipient Raw Material Specifications o
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291827
Title
Excipient Raw Material Specifications p
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291828
Title
Manufacturer MHRA GMP
Study date
2017
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291836
Title
Manufacturer GMP Certificate
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291837
Title
Uniformity of Content: Trazodone Hydrochloride 150mg/tab
Study date
2015
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291792
Title
GMP Approval -Health Canada
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291791
Title
Item 27 Trazocalm - Chemistry and Manufacture Dossier
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291838
Title
Chemistry Component Assessment, February 2025, APVMA
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291839
Title
Packaging Material Specification Trazocalm 50mg: a. Bottle Specification
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291840
Title
Packaging Material Specification Trazocalm 50mg: b. Bottle CoA
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291841
Title
Packaging Material Specification Trazocalm 50mg: c. Cap Specification
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291842
Title
Packaging Material Specification Trazocalm 50mg: d. Cap CoA
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291843
Title
Packaging Material Specification Trazocalm 100mg: e. Bottle Specification
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291844
Title
Packaging Material Specification Trazocalm 100mg: f. Bottle CoA
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291845
Title
Packaging Material Specification Trazocalm 100mg: g. Cap Specification
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291846
Title
Packaging Material Specification Trazocalm 100mg: h. Cap CoA
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291847
Title
Packaging Material Specification Trazocalm 150mg: i. Bottle Specification
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291848
Title
Packaging Material Specification Trazocalm 150mg: j. Bottle CoA
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291849
Title
Packaging Material Specification Trazocalm 150mg: k. Cap Specification
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291850
Title
Packaging Material Specification Trazocalm 150mg: l. Cap CoA
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291851
Title
Packaging Material Specification Absorbent Cotton Specification
Study date
2020
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291852
Title
Packaging Material Specification Absorbent Cotton CoA
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291853
Title
Packaging Material Specification Sillica Gel Sachet Specification
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291854
Title
Packaging Material Specification Sillica Gel Sachet CoA
Study date
2022
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291805
Title
Stability Studies Long Term
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291806
Title
Stability Studies Accelerated
Study date
2021
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291860
Title
Frequency of workplace incidents and injuries in veterinarians, veterinary nurses and veterinary students and measures to control these.
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291856
Title
Pharmacokinetics, bioavailability, and hemodynamic effects of trazodone after intravenous and oral administration of a single dose to dogs
Study date
2013
Auth party contact address
-
Data no
291859
Title
Trazodone: A Review of Its Pharmacological Properties and Its Off-Label Use in Dogs and Cats.
Study date
October 2017
Auth party contact address
-
Data no
293154
Title
Management of Trazodone Overdose with Severe Hypotension. , Camacho, Luis David et al. vol. 2019 2470592. 4 Aug. 2019
Study date
2019
Auth party contact address
-
Data no
293168
Title
Item 27 Trazocalm - Executive Summary -Stage B Update
Study date
September 2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291835
Title
Item 27 Trazocalm - Executive Summary
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291857
Title
2025-09-09 - Final PAA Meeting Record and written advice 148977
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
291858
Title
Project Plan -148977 Trazocalm (signed)
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293161
Title
Effect of penetration enhancers on skin permeation of trazodone hydrochloride from matrix type transdermal formulation through mouse and human cadaver epidermis.
Study date
2006
Auth party contact address
-
Data no
293118
Title
The Use of Trazodone to Facilitate Post-Surgical Confinement in Dogs
Study date
2014
Auth party contact address
-
Data no
293133
Title
Unintentional trazodone
Study date
2018
Auth party contact address
-
Data no
293157
Title
Carcinogenicity of psychotropic drugs: A systematic review of US Food and Drug Administration required preclinical in vivo studies
Study date
2015
Auth party contact address
-
Data no
293140
Title
Assessment of trazodone-induced cardiotoxicity after repeated doses in rats.
Study date
2019
Auth party contact address
-
Data no
293144
Title
Mutagenicity and recombinogenicity evaluation of bupropion hydrochloride and trazodone hydrochloride in somatic cells of Drosophila melanogaster.
Study date
2019
Auth party contact address
-
Data no
293147
Title
Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy: A Comparative ENTIS Cohort Study.
Study date
2023
Auth party contact address
-
Data no
293136
Title
Excretion of trazodone in breast milk.
Study date
1986
Auth party contact address
-
Data no
293143
Title
Evaluation of cytogenetic and DNA damage induced by the antidepressant drug-active ingredients, trazodone and milnacipran, in vitro.
Study date
2017
Auth party contact address
-
Data no
293152
Title
Trazodone - StatPearls.
Study date
2024
Auth party contact address
-
Data no
293128
Title
Pharmacokinetics of trazodone and its major metabolite m-chlorophenylpiperazine in plasma and brain of rats.
Study date
1999
Auth party contact address
-
Data no
293129
Title
Pharmacokinetics, pharmacodynamics and clinical use of trazodone and its active metabolite m-chlorophenylpiperazine in the horse.
Study date
2018
Auth party contact address
-
Data no
293119
Title
Are we done with trazodone? The potential for damage by m-CPP - A metabolite of trazodone
Study date
2007
Auth party contact address
-
Data no
293120
Title
Handbook of Pharmaceutical Excipients a
Study date
2009
Auth party contact address
-
Data no
293121
Title
Handbook of Pharmaceutical Excipients b
Study date
2009
Auth party contact address
-
Data no
293122
Title
Handbook of Pharmaceutical Excipients c
Study date
2009
Auth party contact address
-
Data no
293123
Title
Handbook of Pharmaceutical Excipients d
Study date
2009
Auth party contact address
-
Data no
293124
Title
Handbook of Pharmaceutical Excipients e
Study date
2009
Auth party contact address
-
Data no
293125
Title
Handbook of Pharmaceutical Excipients f
Study date
2009
Auth party contact address
-
Data no
293126
Title
Scientific opinion on the reconsideration of the temporary ADI and refined exposure assessment.
Study date
2015
Auth party contact address
-
Data no
293127
Title
Trazodone Drug Usage Statistics, United States, 2013 - 2020.
Study date
2022
Auth party contact address
-
Data no
293115
Title
Item 27 Trazocalm Health Dossier
Study date
2025
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293116
Title
Trazodone DrugBank Online
Study date
2022
Auth party contact address
-
Data no
293130
Title
PRODUCT MONOGRAPH PrTRAZODONE, Trazodone Hydrochloride Tablets USP
Study date
2012
Auth party contact address
-
Data no
293131
Title
P/0396/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for trazodone (hydrochloride)
Study date
2017
Auth party contact address
-
Data no
293137
Title
Comparative bioavailability of trazodone formulations using stable isotope methodology.
Study date
1984
Auth party contact address
-
Data no
293139
Title
PUBLIC ASSESSMENT REPORT of the Trazodon HCl Sandoz 100 mg, tablets Sandoz B.V.
Study date
2014
Auth party contact address
-
Data no
293134
Title
Using trazodone (Desyrel) in Children and Adolescents
Study date
2012
Auth party contact address
-
Data no
293135
Title
Age-related changes in antidepressant pharmacokinetics and potential drug-drug interactions: a comparison of evidence-based literature and package insert information.
Study date
2012
Auth party contact address
-
Data no
293141
Title
Trazodone Oral. Class: Serotonin Modulators
Study date
2024
Auth party contact address
-
Data no
293142
Title
DESYREL (trazodone hydrochloride) tablets, for oral use Initial U.S. Approval: 1981 FDA HIGHLIGHTS OF PRESCRIBING INFORMATION
Study date
1981
Auth party contact address
-
Data no
293148
Title
Safety Data Sheet 109120
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293149
Title
Safety Data Sheet 5261
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293150
Title
Safety Data Sheet 5261
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293151
Title
U.S. Food and Drug Administration Substances Added to Food
Study date
2025
Auth party contact address
-
Data no
293159
Title
The Top 300 Drugs of 2023.
Study date
2025
Auth party contact address
-
Data no
293160
Title
PRODUCT MONOGRAPH Trazodone Trazodone Hydrochloride Tablets Manufacturer s Standard 50 mg, 100 mg and 150 mg.
Study date
2020
Auth party contact address
-
Data no
293166
Title
Toxicology of Trazodone
Study date
1973
Auth party contact address
-
Data no
293156
Title
Safety Data Sheets for Trazodone API and Trazodone containing products
Study date
2023
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Data no
293167
Title
Trazodone Prescribing for Children With Attention Deficit Hyperactivity Disorder on Medicaid in Oregon.
Study date
2022
Auth party contact address
-
Data no
293164
Title
Sleep Disturbance and Rage Attacks in Opsoclonus-Myoclonus Syndrome: Response to Trazodone.
Study date
2005
Auth party contact address
-
Data no
293165
Title
Management of Sleep Disorders in Children with Neurodevelopmental Disorders: A Review.
Study date
2016
Auth party contact address
-
Data no
293162
Title
Postmortem Forensic Toxicology of Trazodone.
Study date
2000
Auth party contact address
-
Data no
293145
Title
Long-Term Treatment with Trazodone Once-A-Day (TzOAD) in Patients with MDD: An Observational, Prospective Study.
Study date
2023
Auth party contact address
-
Data no
293146
Title
Trazodone--a new assay procedure and some pharmacokinetic parameters. vol. 11,5 (1981): 505-9.
Study date
1981
Auth party contact address
-
Data no
293155
Title
A Case of Trazodone Overdose Successfully Rescued with Lipid Emulsion Therapy.
Study date
2020
Auth party contact address
-
Data no
293132
Title
Estimation of an Appropriate Dose of Trazodone for Paediatric Insomnia and the Potential for a Trazodone-Atomoxetine Interaction. C
Study date
2020
Auth party contact address
-
Data no
293163
Title
A Placebo-Controlled Crossover Trial Using Trazodone in Pediatric Migraine.
Study date
1993
Auth party contact address
-
Data no
293158
Title
Negative immunoregulatory effects of antidepressants: inhibition of interferon and stimulation of interleukin-10 secretion
Study date
1999
Auth party contact address
-
Data no
293153
Title
Trazodone regulates neurotrophic/growth factors, mitogen-activated protein kinases and lactate release in human primary astrocytes. vol. 12 225. 1 Dec. 2015.
Study date
2015
Auth party contact address
-
Data no
293169
Title
Trazodone counteracts the response of microglial cells to inflammatory stimuli.
Study date
2024
Auth party contact address
-
Data no
293170
Title
Donaren. sdrugs.com.
Study date
2025
Auth party contact address
-
Data no
293171
Title
Novel protective mechanisms of antidepressants against 3-nitropropionic acid induced Huntington s-like symptoms: a comparative study.
Study date
2011
Auth party contact address
-
Data no
293117
Title
Use of trazodone as an adjunctive agent in the treatment of canine anxiety disorders: 56 cases (1995-2007).
Study date
2008
Auth party contact address
-
Data no
291855
Title
Item 27 Trazocalm - Environment Dossier
Study date
2024
Auth party contact address
Lvl 24, Tower 3, 300 Barangaroo Avenue Barangaroo Australia
Date
Application Date
Application No
Application Number
149875
Product/Active constituent Name
Application Product Name
AC Z-25 Cy Exxo POUR-ON FOR CATTLE
Application Date
Application Number
149875
Application Product Name
AC Z-25 Cy Exxo POUR-ON FOR CATTLE
Application details
Product name:
AC Z-25 Cy Exxo POUR-ON FOR CATTLE
Product number:
96564
Applicant Name:
AXICHEM PTY LTD
Application purpose and description of use:
Registration of a 25 g/L zeta-cypermethrin pour-on product for the control of cattle lice, house fly, stable fly and buffalo fly in cattle.
Reference details:
50781 - ELANCO AH0487 DEMIZE POUR-ON FOR CATTLE
Active constituents:
Active constituent name
49118 - ZETA-CYPERMETHRIN
Active constituent name
48259 - ZETA-CYPERMETHRIN
Description of data provided:
Data no
291148
Title
Product specifications
Study date
2025
Auth party contact address
9 Palings Court NERANG Australia
Date
Application Date
Application No
Application Number
150062
Product/Active constituent Name
Application Product Name
Earthcare Organic Weedkiller Concentrate
Application Date
Application Number
150062
Application Product Name
Earthcare Organic Weedkiller Concentrate
Application details
Product name:
Earthcare Organic Weedkiller Concentrate
Product number:
90456
Applicant Name:
DULUXGROUP (AUSTRALIA) PTY LTD
Application purpose and description of use:
Variation of product registration to add an additional formulation and alter the product name.
Active constituents:
Active constituent name
61987 - PELARGONIC ACID
Date
Application Date
Application No
Application Number
150115
Product/Active constituent Name
Application Product Name
Quantum Moxypyr Herbicide
Application Date
Application Number
150115
Application Product Name
Quantum Moxypyr Herbicide
Application details
Product name:
Quantum Moxypyr Herbicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 33 g/L IMAZAMOX AS THE AMMONIUM SALT and 15 g/L IMAZAPYR PRESENT AS THE AMMONIUM SALT, soluble concentrate for For the early post-emergence control of certain annual grass and broadleaf weeds in imidazolinone-tolerant wheat, imidazolinone-tolerant barley, imidazolinone-tolerant canola,
as specified in the DIRECTIONS FOR USE section of this label.
Date
Application Date
Application No
Application Number
150116
Product/Active constituent Name
Application Product Name
Quantum Carbendazim 500 SC Fungicide
Application Date
Application Number
150116
Application Product Name
Quantum Carbendazim 500 SC Fungicide
Application details
Product name:
Quantum Carbendazim 500 SC Fungicide
Applicant Name:
QUANTUM AGROSCIENCES HOLDINGS PTY LTD
Application purpose and description of use:
Registration of a 500 g/L Carbendazim, suspension concentrate for the control of fungal diseases on Macadamia Nuts, Chickpeas, Faba Beans, Lentils and Vetch, as per the Directions for Use Table.
Date
Application Date
Application No
Application Number
150063
Product/Active constituent Name
Application Product Name
RAID EXTERMINATOR FLEA & COCKROACH BOMB
Application Date
Application Number
150063
Application Product Name
RAID EXTERMINATOR FLEA & COCKROACH BOMB
Application details
Product name:
RAID EXTERMINATOR FLEA & COCKROACH BOMB
Product number:
67181
Applicant Name:
S.C. JOHNSON & SON PTY LTD
Application purpose and description of use:
Variation to the approved label for minor label amendments and additional pack sizes.
Active constituents:
Active constituent name
44422 - PERMETHRIN
Date
Application Date
Application No
Application Number
150111
Product/Active constituent Name
Application Product Name
Graslan Aerial 3D HiLoad Herbicide
Application Date
Application Number
150111
Application Product Name
Graslan Aerial 3D HiLoad Herbicide
Application details
Product name:
Graslan Aerial 3D HiLoad Herbicide
Product number:
90121
Applicant Name:
FMC AUSTRALASIA PTY LTD
Application purpose and description of use:
Variation of Registration and Label Approval to Extend Uses under Table 4 of the DFU: Aerial and Ground Application to other states.
Reference details:
69266 - GP REGAIN 400 HERBICIDE
69418 - GP REGAIN 200 HERBICIDE
Active constituents:
Active constituent name
57776 - TEBUTHIURON
Active constituent name
88553 - Tebuthiuron
Description of data provided:
Data no
293214
Title
Item 12: Extension of Use to Include Additional States Approved for the Reference Product. Graslan Aerial 3D HiLoad Herbicide.
Study date
12/09/2025
Auth party contact address
Building B 12 Julius Avenue North Ryde Australia
Date
Application Date
Application No
Application Number
150072
Product/Active constituent Name
Application Product Name
BIMEPRAZOL 370 MG/G ORAL PASTE FOR HORSES
Application Date
Application Number
150072
Application Product Name
BIMEPRAZOL 370 MG/G ORAL PASTE FOR HORSES
Application details
Product name:
BIMEPRAZOL 370 MG/G ORAL PASTE FOR HORSES
Product number:
96612
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
Registration of a 370 mg/g omeprazole paste for the treatment and prevention of gastric ulcers in horses and foals.
Reference details:
52962 - GASTROSHIELD PASTE FOR HORSES
Active constituents:
Active constituent name
96613 - Omeprazole
Description of data provided:
Data no
291563
Title
Product specifications
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
291564
Title
Certificate of analysis and specifications
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
291565
Title
Declaration
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
291566
Title
Evidence 1
Study date
2024
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
291567
Title
Evidence 2
Study date
2024
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
291568
Title
Evidence 3
Study date
2024
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Date
Application Date
Application No
Application Number
150073
Product/Active constituent Name
Application Product Name
Omeprazole
Application Date
Application Number
150073
Application Product Name
Omeprazole
Application details
Product name:
Omeprazole
Active name:
Omeprazole
Applicant Name:
BIMEDA (AUSTRALIA) PTY. LIMITED
Application purpose and description of use:
New source of pharmacopoeia active constituent.
Description of data provided:
Data no
293057
Title
Certificates of analysis
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Data no
293058
Title
Certificate
Study date
2025
Auth party contact address
Level 31, Suite 31.01 International Towers 264 George Street SYDNEY Australia
Date
Application Date
Application No
Application Number
150354
Product/Active constituent Name
Application Product Name
UBUNTU 350 WG Insecticide
Application Date
Application Number
150354
Application Product Name
UBUNTU 350 WG Insecticide
Application details
Product name:
UBUNTU 350 WG Insecticide
Product number:
96672
Applicant Name:
PARIJAT INDUSTRIES (INDIA) LIMITED
Application purpose and description of use:
Registration of a 350 g/kg chlorantraniliprole water dispersible granule WG product for the control of Lepidopteran
species of insect pests in Cotton, certain fruit and almond crops; and Pulse crops, as per the Directions for Use.
For the control of African Black Beetle, Argentine Stem Weevil, Argentinian Scarab, Billbugs and other insect pests in
turf
Reference details:
88598 - Surefire Prynova 350 WG Insecticide
Active constituents:
Active constituent name
88437 - Chlorantraniliprole
Description of data provided:
Data no
293114
Title
Consent for use of protected data
Study date
10 September 2025
Auth party contact address
M-77, 1st & 2nd Floor M Block Market Greater Kailash-II NEW DEHLI India
Date
Application Date
Application No
Application Number
150357
Product/Active constituent Name
Application Product Name
EFREN 325 SC Fungicide
Application Date
Application Number
150357
Application Product Name
EFREN 325 SC Fungicide
Application details
Product name:
EFREN 325 SC Fungicide
Product number:
96673
Applicant Name:
PARIJAT INDUSTRIES (INDIA) LIMITED
Application purpose and description of use:
Registration of a 200 g/L azoxystrobin and 125 g/L difenoconazole suspension concentrate product for the control of
various diseases of Carrots, Potatoes and Tomatoes
Reference details:
86917 - Surefire Stellar Top Fungicide
Active constituents:
Active constituent name
67359 - AZOXYSTROBIN
Active constituent name
65789 - DIFENOCONAZOLE
Date
Application Date
Application No
Application Number
150358
Product/Active constituent Name
Application Product Name
BISHAMON 800 WG Fungicide
Application Date
Application Number
150358
Application Product Name
BISHAMON 800 WG Fungicide
Application details
Product name:
BISHAMON 800 WG Fungicide
Product number:
96674
Applicant Name:
PARIJAT INDUSTRIES (INDIA) LIMITED
Application purpose and description of use:
Registration of a 800 g/kg fosetyl-aluminium product for the prevention and control of phytophthora rots in apples,
avocados, ornamentals, peaches and pineapples
Reference details:
69400 - SUREFIRE ALSETYL 800WG SYSTEMIC FUNGICIDE
Active constituents:
Active constituent name
67917 - FOSETYL-ALUMINIUM