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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
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