← FDA Drug Approvals (Drugs@FDA)
ULTRACET
NDA · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 2001-08-15
Drug application
- FDA Application #
NDA021123
- Application type
- New Drug Application
- Brand name
- ULTRACET
- Generic name
- Acetaminophen
- Active ingredients
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- JANSSEN PHARMS
- First approval
- 2001-08-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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