# ISOTRETINOIN
> **ANDA213571** · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2021-04-12
## Drug
- **FDA Application Number:** ANDA213571
- **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:** UPSHER SMITH LABS
- **Manufacturer:** Upsher-Smith Laboratories, LLC
- **First approval:** 2021-04-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213571)
---
*AI Analytics · CC0 1.0*