← FDA Drug Approvals (Drugs@FDA)
PROMETH W/ DEXTROMETHORPHAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: G AND W LABS INC · Approved 1984-10-31
Drug application
- FDA Application #
ANDA088762- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETH W/ DEXTROMETHORPHAN
- Generic name
- Dextromethorphan Hydrobromide
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- G AND W LABS INC
- First approval
- 1984-10-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown