← FDA Drug Approvals (Drugs@FDA)
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2014-07-21
Drug application
- FDA Application #
ANDA202940- 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
- PHARM ASSOC
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- First approval
- 2014-07-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown