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

145159
Product/Active constituent Name

Application Product Name

Pyraflufen-ethyl

Application details

Product name:

Pyraflufen-ethyl

Active name:

Pyraflufen-ethyl

Applicant Name:

CONQUEST CROP PROTECTION PTY LTD

Application purpose and description of use:

Approval of a new source of pyraflufen-ethyl for use in agricultural products The impurity and toxicological profiles of the proposed new source of pyraflufen-ethyl are believed to be similar to those of APVMA-approved sources of pyraflufen-ethyl.

Description of data provided:

Data no
277173
Author
Anon
Title
Five-Batch Analysis of Pyraflufen-ethyl
Study date
June 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
277172
Author
Anon
Title
Manufacturing process of Pyraflufen-ethyl technical
Study date
May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
277171
Author
Flora Bavand
Title
Part 2 - Chemistry and Manufacture
Study date
August 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
277174
Author
Anon
Title
Declaration of Composition for pyraflufen-ethyl
Study date
May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Data no
277175
Author
Anon
Title
Certificate of Analysis
Study date
May 2024
Authorising party
Applicant
Auth party contact address
LEVEL 1, 4 COLLINGWOOD STREET OSBORNE PARK Australia
Date

Application Date

Application No

Application Number

145225
Product/Active constituent Name

Application Product Name

Cropnosys Dimethenamid-P 720 EC Herbicide

Application details

Product name:

Cropnosys Dimethenamid-P 720 EC Herbicide

Product number:

95305

Applicant Name:

CROPNOSYS INDIA PRIVATE LIMITED

Application purpose and description of use:

Registration of a 720 g/L emulsifiable concentrate formulation of Dimethenamid-P. A pre-emergent herbicide for the control of certain broadleaf and grass weeds in the rotational crops of field peas, lupins, chickpeas, green beans, navy beans, sweet corn, corn, green peas, pumpkins and kabocha and post-emergent control of various weeds in poppies as specified in the DIRECTIONS FOR USE table.

Reference details:

65695 - OUTLOOK HERBICIDE

Active constituents:

Active constituent name
56093 - DIMETHENAMID-P
Date

Application Date

Application No

Application Number

145252
Product/Active constituent Name

Application Product Name

TOPRAMEZONE

Application details

Product name:

TOPRAMEZONE

Active name:

TOPRAMEZONE

Applicant Name:

Hebei Lansheng Biotech Co Ltd

Application purpose and description of use:

Approval of Topramezone for use in agricultural chemical products.

Description of data provided:

Data no
277349
Author
V Damnjanovic
Title
Determination of Active Content and Impurity Profile of Topramezone
Study date
October 2021
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
277350
Author
Anon
Title
Topramezone manufacturing process and impurities formation description.
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
277351
Author
C Xiuxiu
Title
Declaration of composition
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
277352
Author
C Xiuxiu
Title
Available packages for Topramezone TC
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Data no
277353
Author
C Xiuxiu
Title
Statement of 5 Batch Size and typical batch size of Topramezone Technical
Study date
August 2024
Authorising party
Applicant
Auth party contact address
Mayu Village Jinzhou City Shijiazhuang City China
Date

Application Date

Application No

Application Number

145224
Product/Active constituent Name

Application Product Name

Cropnosys Mandipropamid 250 SC Fungicide

Application details

Product name:

Cropnosys Mandipropamid 250 SC Fungicide

Product number:

95304

Applicant Name:

CROPNOSYS INDIA PRIVATE LIMITED

Application purpose and description of use:

Registration of a 250 g/L suspension concentrate of mandipropamid for the control of Downy Mildew in Grapes, Lettuce, Leafy Vegetables and Oilseed Poppies

Reference details:

63052 - REVUS FUNGICIDE

Active constituents:

Active constituent name
63073 - MANDIPROPAMID
Date

Application Date

Application No

Application Number

145179
Product/Active constituent Name

Application Product Name

GENFARM EPOXI-PYRACLOSTROBIN SE FUNGICIDE

Application details

Product name:

GENFARM EPOXI-PYRACLOSTROBIN SE FUNGICIDE

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Registration of a suspoemulsion fungicide containing 85 g/L Pyraclostrobin and 62.5 g/L Epoxiconazole for the control of a broad range of fungal diseases in Wheat, Barley and Oat/Oaten hay.
Date

Application Date

Application No

Application Number

145177
Product/Active constituent Name

Application Product Name

Agro-Essence Paraquat 360 Herbicide

Application details

Product name:

Agro-Essence Paraquat 360 Herbicide

Product number:

95277

Applicant Name:

AGRO-ALLIANCE (AUSTRALIA) PTY LTD

Application purpose and description of use:

Registration of a 360 g/L Paraquat Soluble Concentrate (SL) product for the Control of a Wide Range of Grasses and Broadleaf Weeds

Reference details:

83835 - Superquat 360 Herbicide

Active constituents:

Active constituent name
56809 - PARAQUAT DICHLORIDE MANUFACTURING CONCENTRATE
Active constituent name
54043 - PARAQUAT DICHLORIDE MANUFACTURING CONCENTRATE
Date

Application Date

Application No

Application Number

145180
Product/Active constituent Name

Application Product Name

OzCrop Chlorostick 720 SC Fungicide

Application details

Product name:

OzCrop Chlorostick 720 SC Fungicide

Applicant Name:

OZ CROP PTY LTD

Application purpose and description of use:

Registration of a 720 g/L Chlorothalonil Suspension Concentrate (SC) as OzCrop Chlorostick 720 SC Fungicide For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes, turf and vegetables as per the Directions for Use Table. .
Date

Application Date

Application No

Application Number

144833
Product/Active constituent Name

Application Product Name

Tycaprole Insecticide

Application details

Product name:

Tycaprole Insecticide

Product number:

95161

Applicant Name:

Agrocura Limited

Application purpose and description of use:

Registration of Tycaprole Insecticide product for the control of Lepidopteran species of insect pests in certain vegetables as per the Directions for Use. Applicant is applying for registration of Tycaprole Insecticide containing Chlorantraniliprole 200 g/L, formulated as suspension concentrates (SC) product, for the control of Lepidopteran species of insect pests in certain vegetables as per the Directions for Use.

Reference details:

61519 - CORAGEN INSECTICIDE

Active constituents:

Active constituent name
92326 - chlorantraniliprole

Description of data provided:

Data no
275669
Author
Applicant
Title
Exacutive summary
Study date
10/6/2024
Authorising party
Applicant
Auth party contact address
16D, One Capital Place 18 Luard Road Wan Chai Hong Kong
Data no
275670
Author
Applicant
Title
reference product label
Study date
10/06/2024
Authorising party
Applicant
Auth party contact address
16D, One Capital Place 18 Luard Road Wan Chai Hong Kong
Date

Application Date

Application No

Application Number

145176
Product/Active constituent Name

Application Product Name

FlexAg Clethodim 360 Herbicide

Application details

Product name:

FlexAg Clethodim 360 Herbicide

Product number:

95276

Applicant Name:

FLEXAG PTY LTD

Application purpose and description of use:

Registration of a 360 g/L clethodim emulsifiable concentrate (EC) product for the control of certain grass weeds in Beetroot, Cabbage, Canola, Celery, Chickpeas, Cotton, Faba Beans, Field Peas, Forestry, Lentils, Lettuce, Lupins, Mung Beans, Non-Bearing Fruit Trees, Onions, Ornamentals, Peanuts, Potatoes and Soybeans.

Reference details:

87593 - Spalding Clethodim 360 EC Herbicide

Active constituents:

Active constituent name
89227 - Clethodim

Description of data provided:

Data no
277225
Author
Anon
Title
Consent for use of Protected Information
Study date
20 August 2024
Authorising party
Applicant
Auth party contact address
19 Adelaide Pl PORT LINCOLN Australia
Date

Application Date

Application No

Application Number

145211
Product/Active constituent Name

Application Product Name

Cropnosys Azoxystrobin 250 SC Fungicide

Application details

Product name:

Cropnosys Azoxystrobin 250 SC Fungicide

Product number:

95297

Applicant Name:

CROPNOSYS INDIA PRIVATE LIMITED

Application purpose and description of use:

Registration of a 250 g/L soluble concentrate formulation of azoxystrobin for the control of control of various diseases of Grapes, Potatoes, Tomatoes, Cucurbits, Avocados, Mangoes, Passionfruit and Poppies, as per the Directions for Use.

Reference details:

84248 - Raystar Azoxystrobin 250SC Fungicide

Active constituents:

Active constituent name
64896 - AZOXYSTROBIN
Date

Application Date

Application No

Application Number

145190
Product/Active constituent Name

Application Product Name

Cropnosys Diflufenican 500 SC Herbicide

Application details

Product name:

Cropnosys Diflufenican 500 SC Herbicide

Product number:

95287

Applicant Name:

CROPNOSYS INDIA PRIVATE LIMITED

Application purpose and description of use:

Registration of a 500 g/L suspension concentrate of diflufenican for the control of certain weeds in clover-based Pasture, Field Peas, Lentils, Lupins and Oilseed Poppy as specified in the Directions for Use table

Reference details:

85293 - Diflukey Herbicide

Active constituents:

Active constituent name
69078 - DIFLUFENICAN
Date

Application Date

Application No

Application Number

145080
Product/Active constituent Name

Application Product Name

Chlorfenapyr

Application details

Product name:

Chlorfenapyr

Active name:

Chlorfenapyr

Applicant Name:

SHANDONG XINLONG GROUP BIOTECHNOLOGY CO LTD

Application purpose and description of use:

Approval of Chlorfenapyr technical grade material for use in agricultural chemical products.

Description of data provided:

Data no
276745
Author
Ling Fu
Title
Preliminary Analysis and Enforcement Analytical Method of CHLORFENAPYR TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of CHLORFENAPYR TC
Study date
14/09/2021
Authorising party
Applicant
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276746
Author
Nutrichem laboratory Co., Ltd.
Title
Preliminary Analysis and Enforcement Analytical Method of CHLORFENAPYR TC ???Validation of Analytical Methodology for the Assay of Active Ingredient, Impurities and Subsequent 5-Batch Analysis of CHLORFENAPYR TC
Study date
05/2021
Authorising party
Applicant
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276747
Author
Shandong Xinlong Group Biotechnology Co., Ltd.
Title
Declaration of composition - Chlorfenapyr TC
Study date
08/08/2024
Authorising party
Applicant
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Data no
276744
Author
Shandong Xinlong Group Biotechnology Co., Ltd.
Title
Manufacturing Process of Chlorfenapyr TC and Impurities Justification
Study date
13/12/2021
Authorising party
Applicant
Auth party contact address
No.26 Tianliu Section No.3 Road Tianliu Town Shouguang, Weifang China
Date

Application Date

Application No

Application Number

145183
Product/Active constituent Name

Application Product Name

PROPENTOFYLLINE

Application details

Product name:

PROPENTOFYLLINE

Active name:

PROPENTOFYLLINE

Applicant Name:

INTERVET AUSTRALIA PTY LIMITED

Application purpose and description of use:

Approval of Propentofylline source for use in veterinary chemical products

Description of data provided:

Data no
276906
Author
Anon
Title
Analytical test procedure AI site
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276907
Author
Anon
Title
Validation of Analytical Procedure AI Site Summary
Study date
December 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276908
Author
Anon
Title
Analytical method validation protocol & report for related substances by HPLC
Study date
8 September 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276909
Author
Anon
Title
Analytical method validation protocol & report for Assay by HPLC
Study date
19 August 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276910
Author
Anon
Title
Analytical method validation protocol & report determination residual solvents by GC-HS
Study date
21 October 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276911
Author
Anon
Title
Analytical method verification protocol & report of DSC method
Study date
22 October 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276912
Author
Anon
Title
Analytical method verification protocol & report of PSD method
Study date
24 October 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276913
Author
Anon
Title
Analytical method verification protocol & report for identification by FTIR
Study date
24 October 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276914
Author
Anon
Title
Batch Analyses & Results AI-Site
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276915
Author
Anon
Title
CoA J13910223_001
Study date
2 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276916
Author
Anon
Title
CoA J13910223_002
Study date
2 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276917
Author
Anon
Title
CoA J13910223_003
Study date
2 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276918
Author
Anon
Title
CoA J13910223_004
Study date
2 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276919
Author
Anon
Title
CoA J73910223_001
Study date
2 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276892
Author
MSD Animal Health
Title
CoA 0000707863 MSD
Study date
21 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276893
Author
MSD Animal Health
Title
CoA 0000728313 MSD
Study date
22 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276894
Author
MSD Animal Health
Title
CoA 0000728313 MSD
Study date
22 August 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276895
Author
MSD Animal Health
Title
CoA 0000732422 MSD New Site
Study date
9 November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276896
Author
MSD Animal Health
Title
CoA 0000732420 MSD New Site
Study date
9 November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276897
Author
MSD Animal Health
Title
CoA 0000732423 MSD New Site
Study date
9 November 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276889
Author
MSD Animal Health
Title
Comparison Batch analyses results
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276890
Author
Anon
Title
API Specification_Aug2019
Study date
August 2019
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276898
Author
Anon
Title
Hygroscopicity Report
Study date
26 May 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276899
Author
Anon
Title
Manufacturing process new AI site
Study date
December 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276900
Author
Anon
Title
Structural Elucidation Report (3 batches)
Study date
20 June 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276901
Author
Anon
Title
Impurities new AI site
Study date
April 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276902
Author
Anon
Title
Fate & Purge Report
Study date
29 September 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276903
Author
Anon
Title
Assessment and Control of DNA Reactive Genotoxic (Mutagenic) Impurities
Study date
30 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276904
Author
Anon
Title
Initial Risk Assessment Report
Study date
30 March 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276905
Author
Anon
Title
Standard specification new AI site
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276920
Author
Anon
Title
Justification of specification AI-site
Study date
December 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276891
Author
MSD Animal Health
Title
Expert Report
Study date
15 July 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276886
Author
Anon
Title
ASMFv4 Part 1_Aug2024
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276887
Author
Anon
Title
ASMFv4 Part 2_Aug2024
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276888
Author
MSD Animal Health
Title
Executive Summary
Study date
21 August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276921
Author
Anon
Title
Forced Degradation Study Protocol AI-site
Study date
25 November 2022
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276922
Author
Anon
Title
Forced Degradation Study Report AI-site
Study date
12 January 2023
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Data no
276923
Author
Anon
Title
Stability data AI-Site
Study date
August 2024
Authorising party
Applicant
Auth party contact address
91-105 Harpin Street BENDIGO EAST Australia
Date

Application Date

Application No

Application Number

144883
Product/Active constituent Name

Application Product Name

SWIFT POUR-ON FOR SHEEP

Application details

Product name:

SWIFT POUR-ON FOR SHEEP

Product number:

95184

Applicant Name:

NUTRIEN AG SOLUTIONS LIMITED

Application purpose and description of use:

Registration of a 4.0 mg/ml abamectin and 35.0 mg/ml imidacloprid liquid pour-on product for the treatment and control of susceptible strains of lice (Bovicola ovis) on sheep, including synthetic pyrethroid resistant lice, when applied up to 7 days after shearing.

Reference details:

85544 - FENNEC POUR-ON FOR SHEEP

Active constituents:

Active constituent name
83130 - Abamectin
Active constituent name
83018 - Imidacloprid

Description of data provided:

Data no
275790
Author
Anon
Title
Swift Pour-On for Sheep Specifications
Study date
21-Jun-2024
Authorising party
Applicant
Auth party contact address
Level 5, Building A, 26 Talavera Road MACQUARIE PARK Australia
Date

Application Date

Application No

Application Number

145189
Product/Active constituent Name

Application Product Name

Cropnosys Propaquizafop 100EC Herbicide

Application details

Product name:

Cropnosys Propaquizafop 100EC Herbicide

Product number:

95286

Applicant Name:

CROPNOSYS INDIA PRIVATE LIMITED

Application purpose and description of use:

Registration of a 100 g/L emulsifiable concentrate of propaquizafop for post-emergence selective weed control of annual grasses in broadleaf crops and legume pastures as specified in the Directions for Use table.

Reference details:

60764 - SHOGUN HERBICIDE

Active constituents:

Active constituent name
44365 - PROPAQUIZAFOP
Date

Application Date

Application No

Application Number

144731
Product/Active constituent Name

Application Product Name

AURAZOL MINIDOSE CATTLE DRENCH

Application details

Product name:

AURAZOL MINIDOSE CATTLE DRENCH

Product number:

95117

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

Registration of a 112.5 g/L ALBENDAZOLE Oral Drench product is proposed for the control of benzimidazole-sensitive mature and immature gastrointestinal roundworms (including inhibited type II Ostertagia larvae), lungworms, tapeworms and to aid in the control of adult liver fluke in cattle. It also reduces the output of viable worm and fluke eggs and for hook drenching of beef and dairy cattle.

Reference details:

85538 - INDEPENDENTS OWN ALBEMAX MINI-DOSE CATTLE DRENCH

Description of data provided:

Data no
274371
Author
Anon
Title
Finished Product Specs
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

145186
Product/Active constituent Name

Application Product Name

eChem Promid 500 WG Herbicide

Application details

Product name:

eChem Promid 500 WG Herbicide

Product number:

95283

Applicant Name:

ECHEM (AUST) PTY LIMITED

Application purpose and description of use:

Registration of a 500 g/kg propyzamide water dispersible granule product for selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns and legume seed crops and pastures

Reference details:

88974 - Sabakem Propyzamide 500 WG Herbicide

Active constituents:

Active constituent name
80007 - PROPYZAMIDE
Date

Application Date

Application No

Application Number

145219
Product/Active constituent Name

Application Product Name

ILIUM TEMVET INJECTION

Application details

Product name:

ILIUM TEMVET INJECTION

Product number:

67612

Applicant Name:

TROY LABORATORIES PTY LTD

Application purpose and description of use:

Variation of registration to amend product formulation.

Active constituents:

Active constituent name
81514 - BUPRENORPHINE HYDROCHLORIDE
Active constituent name
81514 - BUPRENORPHINE HYDROCHLORIDE

Description of data provided:

Data no
277203
Author
Troy Laboratories
Title
Supporting information
Study date
2024
Authorising party
Applicant
Auth party contact address
37 GLENDENNING ROAD GLENDENNING Australia
Date

Application Date

Application No

Application Number

144732
Product/Active constituent Name

Application Product Name

Albendazole

Application details

Product name:

Albendazole

Active name:

Albendazole

Applicant Name:

AURA LABORATORIES LIMITED

Application purpose and description of use:

New source of pharmacopoeia active constituent.

Description of data provided:

Data no
276301
Author
Anon
Title
Active Certificates of analysis
Study date
2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Data no
279807
Author
Registrant
Title
AURA - Albendazole API -Qquery response - Justification for residual solvent ' Mesityl oxide' limits in the COA
Study date
October 2024
Authorising party
Applicant
Auth party contact address
7 Puninga Lane Takanini Auckland New Zealand
Date

Application Date

Application No

Application Number

145160
Product/Active constituent Name

Application Product Name

F.S.A. 24DB Herbicide

Application details

Product name:

F.S.A. 24DB Herbicide

Product number:

87501

Applicant Name:

FOUR SEASONS AGRIBUSINESS PTY LTD

Application purpose and description of use:

Variation of product registration to update formulation.

Active constituents:

Active constituent name
68528 - 2,4-DB
Active constituent name
47083 - 2,4-DB

Description of data provided:

Data no
277183
Author
Emma Waller
Title
Consent For Use of Confidential Commercial Information
Study date
19 August 2024
Authorising party
Nufarm Australia Ltd
Data no
277184
Author
Emma Waller
Title
Formulation details for the above reference product
Study date
19 August 2024
Authorising party
Nufarm Australia Ltd
Auth party contact address
103-105 Pipe Road, Laverton North VIC 3026