← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE DM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAI HOLDINGS · Approved 2006-02-14
Drug application
- FDA Application #
ANDA040649- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE DM
- Generic name
- PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PAI HOLDINGS
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- First approval
- 2006-02-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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