# PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
> **NDA011265** · New Drug Application · Sponsor: ANI PHARMS · Approved 1957-12-03
## Drug
- **FDA Application Number:** NDA011265
- **Application type:** New Drug Application
- **Brand name:** PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Generic name:** PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- **Dosage form:** SYRUP
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ANI PHARMS
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 1957-12-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011265)
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