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FDA NDA · NDA020516

CHILDRENS MOTRIN

ibuprofen

Sponsor: KENVUE BRANDS

APPLICATION
NDA020516
TYPE
NDA
ORIGINAL APPROVAL
1995-06-16
LATEST ACTION
2026-07-22
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S MOTRIN · ReferenceOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL

Approval history

2026-07-22Labeling · Supplement 45 · standard — Letter ↗AP
2021-02-19Manufacturing (CMC) · Supplement 38 — Letter ↗AP
2018-11-29Labeling · Supplement 36 · standard — Label ↗AP
2017-03-14Labeling · Supplement 35 · standard — Label ↗AP
2017-01-09Manufacturing (CMC) · Supplement 34 · standardAP
2016-06-17Manufacturing (CMC) · Supplement 32 · standardAP
2016-06-16Labeling · Supplement 33 · standard — Letter ↗AP
2015-12-07Manufacturing (CMC) · Supplement 31 · standardAP
2015-04-16Labeling · Supplement 30 · standard — Label ↗AP
2014-12-11Labeling · Supplement 29 · standard — Letter ↗AP
2012-11-19Manufacturing (CMC) · Supplement 28 · standardAP
2012-08-12Manufacturing (CMC) · Supplement 26 · standardAP
2011-12-06Labeling · Supplement 24 · standard — Letter ↗AP
2010-10-19Labeling · Supplement 22 · unknown — Letter ↗AP
2009-04-29Labeling · Supplement 21 · standard — Letter ↗AP
2006-06-22Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2005-12-07Labeling · Supplement 18 · standard — Letter ↗AP
2005-02-07Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 12 · standard — Letter ↗AP
2003-10-28Labeling · Supplement 11 · standard — Letter ↗AP
2001-05-02Manufacturing (CMC) · Supplement 8 · standardAP
2000-10-02Labeling · Supplement 6 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 7 · standardAP
1999-09-13Labeling · Supplement 4 · standard — Label ↗AP
1998-12-18Manufacturing (CMC) · Supplement 3 · standardAP
1998-06-04Labeling · Supplement 2 · standardAP
1997-03-31Labeling · Supplement 1 · standardAP
1995-06-16Type 8 - Partial Rx to OTC Switch · Original · standardAP
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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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