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ACETAMINOPHEN AND IBUPROFEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: BIONPHARMA · Approved 2023-08-01
Drug application
- FDA Application #
ANDA216999
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ACETAMINOPHEN AND IBUPROFEN
- Generic name
- ACETAMINOPHEN AND IBUPROFEN
- Active ingredients
- ACETAMINOPHEN; IBUPROFEN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- BIONPHARMA
- Manufacturer
- AMERISOURCE BERGEN
- First approval
- 2023-08-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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