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APX-QUETIAPINE XR quetiapine (as fumarate) 300mg modified release tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
APX-QUETIAPINE XR quetiapine (as fumarate) 300mg modified release tablet blister pack
Approved
STANDARD
APX-QUETIAPINE XR quetiapine (as fumarate) 300mg modified release tablet blister pack
Arrotex Pharmaceuticals Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
31f53ab847fdbd86
Company
Arrotex Pharmaceuticals Pty Ltd
Type
Standard
Approval Details
Approval Id
31f53ab847fdbd86
Product Name
APX-QUETIAPINE XR quetiapine (as fumarate) 300mg modified release tablet blister pack
Artg Id
199867
Artg Name
APX-QUETIAPINE XR quetiapine (as fumarate) 300mg modified release tablet blister pack
Sponsor
Arrotex Pharmaceuticals Pty Ltd
Company Detail Path
/organization/arrotex-pharmaceuticals-pty-ltd
Artg Date
2014-01-17
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-CMI-02282-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-02281-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
31f53ab847fdbd86
Type
Standard
Back to TGA Approvals