Composition
- Active ingredients
- ISOTRETINOIN 40MG
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 ANDA075945.
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
- Amnesteem
- Active substance
- isotretinoin
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Mylan Pharms Inc
- Status
- Prescription
- FDA approval
- 8 Nov 2002
- Application
- ANDA075945-003