← FDA Drug Approvals (Drugs@FDA)
ISOTRETINOIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2025-10-07
Drug application
- FDA Application #
ANDA216097- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOTRETINOIN
- Generic name
- ISOTRETINOIN
- Active ingredients
- ISOTRETINOIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- AMNEAL PHARMS NY
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2025-10-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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