← FDA Drug Approvals (Drugs@FDA)
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2009-12-09
Drug application
- FDA Application #
ANDA090485- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Generic name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Active ingredients
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMNEAL PHARMS
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2009-12-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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