← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE W/ DEXTROMETHORPHAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARMOBEDIENT · Approved 1985-01-04
Drug application
- FDA Application #
ANDA088864- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE W/ DEXTROMETHORPHAN
- Generic name
- PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PHARMOBEDIENT
- Manufacturer
- Xttrium Laboratories, Inc
- First approval
- 1985-01-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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