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PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2026-03-12
Drug application
- FDA Application #
ANDA218264- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Generic name
- Dextromethorphan Hydrobromide
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HETERO LABS LTD III
- First approval
- 2026-03-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown