← FDA DRUG APPROVALS

FDA NDA · NDA020601

JUNIOR STRENGTH MOTRIN

Sponsor: KENVUE BRANDS

APPLICATION
NDA020601
TYPE
NDA
ORIGINAL APPROVAL
1996-11-15
LATEST ACTION
2018-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

JUNIOR STRENGTH MOTRIN · ReferenceDiscontinued
IBUPROFEN 100MG · TABLET, CHEWABLE · ORAL
CHILDREN'S MOTRIN · ReferenceDiscontinued
IBUPROFEN 50MG · TABLET, CHEWABLE · ORAL

Approval history

2018-10-02Labeling · Supplement 21 · standard — Label ↗AP
2017-05-15Labeling · Supplement 20 · standard — Label ↗AP
2010-10-18Labeling · Supplement 18 · unknown — Letter ↗AP
2009-04-28Labeling · Supplement 17 · standard — Letter ↗AP
2006-05-10Labeling · Supplement 14 · standard — Letter ↗AP
2006-02-27Labeling · Supplement 13 · standard — Letter ↗AP
2002-08-05Manufacturing (CMC) · Supplement 7 · standardAP
2001-05-02Manufacturing (CMC) · Supplement 6 · standardAP
1999-12-29Labeling · Supplement 5 · standardAP
1999-12-29Manufacturing (CMC) · Supplement 4 · standardAP
1999-09-13Labeling · Supplement 2 · standard — Label ↗AP
1998-12-18Manufacturing (CMC) · Supplement 3 · standardAP
1998-06-12Labeling · Supplement 1 · standardAP
1996-11-15Type 8 - Partial Rx to OTC Switch · Original · standardAP
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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