# ISOTRETINOIN
> **ANDA218194** · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2024-01-29
## Drug
- **FDA Application Number:** ANDA218194
- **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:** AUROBINDO PHARMA
- **Manufacturer:** Aurobindo Pharma Limited
- **First approval:** 2024-01-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218194)
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