← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XGEN PHARMS · Approved 2008-04-24
Drug application
- FDA Application #
ANDA040737- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- XGEN PHARMS
- Manufacturer
- XGen Pharmaceuticals DJB, Inc.
- First approval
- 2008-04-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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