# ACCUTANE
> **NDA018662** · New Drug Application · Sponsor: HOFFMANN LA ROCHE · Approved 1982-05-07
## Drug
- **FDA Application Number:** NDA018662
- **Application type:** New Drug Application
- **Brand name:** ACCUTANE
- **Generic name:** Isotretinoin
- **Active ingredients:** ISOTRETINOIN
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** HOFFMANN LA ROCHE
- **First approval:** 1982-05-07
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018662)
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