← FDA Drug Approvals (Drugs@FDA)
ZANTAC
NDA · New Drug Application · Sponsor: PAI HOLDINGS PHARM · Approved 1984-10-19
Drug application
- FDA Application #
NDA019090
- Application type
- New Drug Application
- Brand name
- ZANTAC
- Generic name
- Ranitidine Hydrochloride
- Active ingredients
- RANITIDINE HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
- Sponsor
- PAI HOLDINGS PHARM
- First approval
- 1984-10-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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