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BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL MOLECULAR · Approved 2020-04-17
Drug application
- FDA Application #
ANDA213125- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Generic name
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
- Active ingredients
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CHARTWELL MOLECULAR
- Manufacturer
- Chartwell Governmental & Specialty RX, LLC
- First approval
- 2020-04-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown