← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS US · Approved 2004-09-23
Drug application
- FDA Application #
ANDA076925- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN
- Generic name
- IBUPROFEN
- Active ingredients
- IBUPROFEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PADAGIS US
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- First approval
- 2004-09-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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