← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IVAX SUB TEVA PHARMS · Approved 1973-10-26
Drug application
- FDA Application #
ANDA083603- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- Promethazine Hydrochloride
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- IVAX SUB TEVA PHARMS
- First approval
- 1973-10-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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