# FLUOXETINE HYDROCHLORIDE
> **ANDA209419** · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2017-11-16
## Drug
- **FDA Application Number:** ANDA209419
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** FLUOXETINE HYDROCHLORIDE
- **Generic name:** FLUOXETINE
- **Active ingredients:** FLUOXETINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PH HEALTH
- **Manufacturer:** Endo USA, Inc.
- **First approval:** 2017-11-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209419)
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