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ORATANE isotretinoin 5mg capsule blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
ORATANE isotretinoin 5mg capsule blister pack
Approved
STANDARD
ORATANE isotretinoin 5mg capsule blister pack
Arrotex Pharmaceuticals Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
98b9a11e38a62253
Company
Arrotex Pharmaceuticals Pty Ltd
Type
Standard
Approval Details
Approval Id
98b9a11e38a62253
Product Name
ORATANE isotretinoin 5mg capsule blister pack
Artg Id
127499
Artg Name
ORATANE isotretinoin 5mg capsule blister pack
Sponsor
Arrotex Pharmaceuticals Pty Ltd
Company Detail Path
/organization/arrotex-pharmaceuticals-pty-ltd
Artg Date
2009-02-09
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-02515-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-02514-1
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
98b9a11e38a62253
Type
Standard
Back to TGA Approvals