← FDA DRUG APPROVALS

FDA NDA · NDA020944

JUNIOR STRENGTH ADVIL

ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020944
TYPE
NDA
ORIGINAL APPROVAL
1998-12-18
LATEST ACTION
2026-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ADVILOver-the-counter
IBUPROFEN 50MG · TABLET, CHEWABLE · ORAL
JUNIOR STRENGTH ADVILOver-the-counter
IBUPROFEN 100MG · TABLET, CHEWABLE · ORAL

Approval history

2026-05-01Labeling · Supplement 17 · standard — Letter ↗AP
2017-12-26Labeling · Supplement 13 · standardAP
2017-03-27Labeling · Supplement 11 · standard — Label ↗AP
2014-02-13Manufacturing (CMC) · Supplement 10AP
2009-05-19Labeling · Supplement 8 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 6 · standard — Letter ↗AP
2006-04-04Labeling · Supplement 5 · standard — Letter ↗AP
2004-12-20Labeling · Supplement 3 · standard — Review ↗AP
2004-12-20Labeling · Supplement 2 · standard — Review ↗AP
1998-12-18Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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