← FDA Drug Approvals (Drugs@FDA)
IBUPROFEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAI HOLDINGS PHARM · Approved 2024-11-08
Drug application
- FDA Application #
ANDA214789- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IBUPROFEN
- Generic name
- IBUPROFEN
- Active ingredients
- IBUPROFEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- PAI HOLDINGS PHARM
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- First approval
- 2024-11-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown