# MYORISAN
> **ANDA076485** · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2012-01-19
## Drug
- **FDA Application Number:** ANDA076485
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MYORISAN
- **Generic name:** ISOTRETINOIN
- **Active ingredients:** ISOTRETINOIN
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** UPSHER SMITH LABS
- **Manufacturer:** Mayne Pharma
- **First approval:** 2012-01-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076485)
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