# PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
> **ANDA040902** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2009-08-25
## Drug
- **FDA Application Number:** ANDA040902
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
- **Generic name:** PROMETHAZINE AND PHENYLEPHRINE
- **Active ingredients:** PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL PHARMS
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 2009-08-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040902)
---
*AI Analytics · CC0 1.0*