← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2015-08-26
Drug application
- FDA Application #
ANDA200963- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
- Generic name
- PROMETHAZINE, PHENYLEPHRINE, CODEINE
- Active ingredients
- CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMNEAL PHARMS
- Manufacturer
- Amneal Pharmaceuticals LLC
- First approval
- 2015-08-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown