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PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2014-12-23
Drug application
- FDA Application #
ANDA040674- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
- Generic name
- Codeine Phosphate
- Active ingredients
- CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- HIKMA
- First approval
- 2014-12-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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