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ACETAMINOPHEN AND IBUPROFEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TARO · Approved 2026-01-02
Drug application
- FDA Application #
ANDA219053
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ACETAMINOPHEN AND IBUPROFEN
- Generic name
- ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS
- Active ingredients
- ACETAMINOPHEN; IBUPROFEN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- TARO
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- First approval
- 2026-01-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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