← FDA Drug Approvals (Drugs@FDA)
COMBOGESIC
NDA · New Drug Application · Sponsor: AFT PHARMS US · Approved 2023-03-01
Drug application
- FDA Application #
NDA209471
- Application type
- New Drug Application
- Brand name
- COMBOGESIC
- Generic name
- ACETAMINOPHEN AND IBUPROFEN
- Active ingredients
- ACETAMINOPHEN; IBUPROFEN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AFT PHARMS US
- Manufacturer
- Hikma Pharmaceuticals USA Inc
- First approval
- 2023-03-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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