← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2007-06-18
Drug application
- FDA Application #
ANDA078558
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN
- Generic name
- IBUPROFEN
- Active ingredients
- IBUPROFEN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMNEAL PHARMS NY
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2007-06-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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