# ISOTRETINOIN
> **ANDA205063** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL · Approved 2021-03-31
## Drug
- **FDA Application Number:** ANDA205063
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ISOTRETINOIN
- **Generic name:** ISOTRETINOIN
- **Active ingredients:** ISOTRETINOIN
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ACTAVIS LABS FL
- **Manufacturer:** Actavis Pharma, Inc.
- **First approval:** 2021-03-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205063)
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