← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
NDA · New Drug Application · Sponsor: ANI PHARMS · Approved 1957-12-03
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown