← FDA DRUG APPROVALS

FDA NDA · NDA019012

MOTRIN MIGRAINE PAIN

Sponsor: KENVUE BRANDS

APPLICATION
NDA019012
TYPE
NDA
ORIGINAL APPROVAL
1984-05-18
LATEST ACTION
2021-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Over-the-counter

Products

MOTRIN MIGRAINE PAINDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
NUPRINDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
MOTRIN IB · ReferenceOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
NUPRINDiscontinued
IBUPROFEN 200MG · TABLET · ORAL

Approval history

2021-11-16Labeling · Supplement 59 · standard — Letter ↗AP
2021-01-07Manufacturing (CMC) · Supplement 58 · standard — Label ↗AP
2017-03-16Labeling · Supplement 57 · standard — Label ↗AP
2017-03-16Labeling · Supplement 56 · standard — Label ↗AP
2016-08-18Labeling · Supplement 55 · standard — Label ↗AP
2016-05-06Manufacturing (CMC) · Supplement 54 · standardAP
2015-07-31Manufacturing (CMC) · Supplement 53 · standard — Review ↗AP
2014-03-11Manufacturing (CMC) · Supplement 52 · standard — Review ↗AP
2013-03-28Manufacturing (CMC) · Supplement 50 · standardAP
2012-12-04Manufacturing (CMC) · Supplement 49 · standardAP
2010-10-21Labeling · Supplement 46 · unknown — Letter ↗AP
2009-04-24Labeling · Supplement 43 · standard — Letter ↗AP
2007-11-20Labeling · Supplement 40 · standard — Letter ↗AP
2006-12-08Manufacturing (CMC) · Supplement 38 — Letter ↗AP
2006-02-08Labeling · Supplement 37 · standard — Letter ↗AP
2003-10-28Labeling · Supplement 34 · standard — Letter ↗AP
2002-03-27Manufacturing (CMC) · Supplement 30 · standardAP
2001-09-07Labeling · Supplement 28 · standard — Label ↗AP
2001-05-02Manufacturing (CMC) · Supplement 27 · standardAP
2001-03-05Manufacturing (CMC) · Supplement 26 · standardAP
2001-01-03Manufacturing (CMC) · Supplement 25 · standardAP
2000-10-02Labeling · Supplement 24 · standardAP
2000-08-25Labeling · Supplement 17 · standardAP
2000-03-22Manufacturing (CMC) · Supplement 22 · standardAP
2000-03-22Manufacturing (CMC) · Supplement 23 · standardAP
2000-02-25Efficacy · Supplement 16 · standard — Review ↗AP
2000-02-07Manufacturing (CMC) · Supplement 19 · standardAP
1999-12-06Manufacturing (CMC) · Supplement 18 · standardAP
1999-11-21Manufacturing (CMC) · Supplement 20 · standardAP
1999-11-21Manufacturing (CMC) · Supplement 21 · standardAP
1997-03-31Labeling · Supplement 3AP
1996-04-10Manufacturing (CMC) · Supplement 14 · standardAP
1995-11-20Manufacturing (CMC) · Supplement 13 · standardAP
1995-01-10Manufacturing (CMC) · Supplement 12 · standardAP
1994-03-25Manufacturing (CMC) · Supplement 11 · standardAP
1990-12-17Manufacturing (CMC) · Supplement 10 · standardAP
1990-12-17Manufacturing (CMC) · Supplement 9 · standardAP
1990-10-02Manufacturing (CMC) · Supplement 8 · standardAP
1990-10-02Manufacturing (CMC) · Supplement 6 · standardAP
1989-07-25Manufacturing (CMC) · Supplement 7 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →