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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

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Drugs@FDA application overview
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