# SERTRALINE HYDROCHLORIDE
> **ANDA218853** · Abbreviated New Drug Application (Generic) · Sponsor: ZENARA · Approved 2025-07-16
## Drug
- **FDA Application Number:** ANDA218853
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SERTRALINE HYDROCHLORIDE
- **Generic name:** SERTRALINE HYDROCHLORIDE
- **Active ingredients:** SERTRALINE HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZENARA
- **Manufacturer:** Cipla USA Inc.
- **First approval:** 2025-07-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218853)
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