← FDA DRUG APPROVALS

FDA NDA · NDA209471

COMBOGESIC

acetaminophen and ibuprofen

Sponsor: AFT PHARMS US

APPLICATION
NDA209471
TYPE
NDA
ORIGINAL APPROVAL
2023-03-01
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COMBOGESIC · ReferencePrescription
ACETAMINOPHEN 325MG, IBUPROFEN 97.5MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 1 · standardLabelAP
2023-03-01Type 4 - New Combination · Original · standardLetterAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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