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PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GENUS · Approved 2006-12-07
Drug application
- FDA Application #
ANDA040654- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
- Active ingredients
- PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GENUS
- Manufacturer
- Genus Lifesciences Inc.
- First approval
- 2006-12-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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