← FDA DRUG APPROVALS

FDA NDA · NDA020589

CHILDRENS ADVIL

ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020589
TYPE
NDA
ORIGINAL APPROVAL
1996-06-27
LATEST ACTION
2026-06-26
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S ADVIL-FLAVOREDOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
CHILDREN'S ADVILOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL

Approval history

2026-06-26Labeling · Supplement 44 · standard — Letter ↗AP
2026-05-01Labeling · Supplement 43 · standard — Letter ↗AP
2022-09-20Manufacturing (CMC) · Supplement 39 — Letter ↗AP
2018-08-30Labeling · Supplement 37 · standard — Label ↗AP
2017-06-21Labeling · Supplement 35 · standard — Letter ↗AP
2017-03-23Labeling · Supplement 34 · standard — Letter ↗AP
2016-07-28Manufacturing (CMC) · Supplement 33 · standardAP
2013-12-20Manufacturing (CMC) · Supplement 29 · standard — Label ↗AP
2013-06-12Manufacturing (CMC) · Supplement 32 · standardAP
2012-12-07Manufacturing (CMC) · Supplement 31 · standardAP
2012-09-04Manufacturing (CMC) · Supplement 30 · standardAP
2010-09-02Labeling · Supplement 26 · standard — Letter ↗AP
2009-05-19Labeling · Supplement 24 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 23 · standard — Letter ↗AP
2005-12-07Labeling · Supplement 19 · standard — Letter ↗AP
2005-03-18Labeling · Supplement 17 · standard — Label ↗AP
2002-11-14Labeling · Supplement 15 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 12 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 13 · standard — Label ↗AP
2001-08-02Manufacturing (CMC) · Supplement 14 · standardAP
2000-08-25Labeling · Supplement 9 · standardAP
2000-07-14Manufacturing (CMC) · Supplement 11 · standardAP
2000-03-30Manufacturing (CMC) · Supplement 10 · standardAP
1999-10-17Manufacturing (CMC) · Supplement 8 · standardAP
1998-10-14Manufacturing (CMC) · Supplement 6 · standardAP
1998-05-05Manufacturing (CMC) · Supplement 4 · standardAP
1997-11-07Manufacturing (CMC) · Supplement 1 · standardAP
1996-06-27Type 8 - Partial Rx to OTC Switch · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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