Composition
- Active ingredients
- ISOTRETINOIN 20MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA076041.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Sotret
- Active substance
- isotretinoin
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Sun Pharm Inds LTD
- Status
- Discontinued
- FDA approval
- 24 Dec 2002
- Application
- ANDA076041-002