← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 2012-06-29
Drug application
- FDA Application #
ANDA200386- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Generic name
- PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Active ingredients
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- COSETTE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- First approval
- 2012-06-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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