# SERTRALINE HYDROCHLORIDE
> **ANDA078861** · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2008-10-31
## Drug
- **FDA Application Number:** ANDA078861
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SERTRALINE HYDROCHLORIDE
- **Generic name:** SERTRALINE HYDROCHLORIDE
- **Active ingredients:** SERTRALINE HYDROCHLORIDE
- **Dosage form:** CONCENTRATE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AUROBINDO PHARMA
- **Manufacturer:** Rising Pharma Holdings, Inc.
- **First approval:** 2008-10-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078861)
---
*MORVS · CC0 1.0*