← FDA Drug Approvals (Drugs@FDA)
PROMETH VC W/ CODEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 1984-10-31
Drug application
- FDA Application #
ANDA088764
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETH VC W/ CODEINE
- Generic name
- Codeine Phosphate
- Active ingredients
- CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- CHARTWELL RX
- First approval
- 1984-10-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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