← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 1997-08-26
Drug application
- FDA Application #
ANDA040151- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Generic name
- Codeine Phosphate
- Active ingredients
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- HIKMA
- First approval
- 1997-08-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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