# PROMETHAZINE HYDROCHLORIDE
> **ANDA040596** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA · Approved 2005-11-18
## Drug
- **FDA Application Number:** ANDA040596
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE
- **Generic name:** PROMETHAZINE HYDROCHLORIDE
- **Active ingredients:** PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS PHARMS USA
- **Manufacturer:** Zydus Pharmaceuticals USA Inc.
- **First approval:** 2005-11-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040596)
---
*AI Analytics · CC0 1.0*