← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2013-04-24
Drug application
- FDA Application #
ANDA200894- 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
- Prescription
- Sponsor
- AMNEAL PHARMS
- First approval
- 2013-04-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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