# SARAFEM
> **NDA021860** · New Drug Application · Sponsor: APIL · Approved 2006-05-19
## Drug
- **FDA Application Number:** NDA021860
- **Application type:** New Drug Application
- **Brand name:** SARAFEM
- **Generic name:** Fluoxetine Hydrochloride
- **Active ingredients:** FLUOXETINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Discontinued
- **Sponsor:** APIL
- **First approval:** 2006-05-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021860)
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