# SERTRALINE HYDROCHLORIDE
> **ANDA219655** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2026-01-28
## Drug
- **FDA Application Number:** ANDA219655
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SERTRALINE HYDROCHLORIDE
- **Generic name:** SERTRALINE
- **Active ingredients:** SERTRALINE HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals NY LLC
- **First approval:** 2026-01-28
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219655)
---
*MORVS · CC0 1.0*