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FDA NDA · NDA019842

MOTRIN

Sponsor: MCNEIL CONSUMER

APPLICATION
NDA019842
TYPE
NDA
ORIGINAL APPROVAL
1989-09-19
LATEST ACTION
2007-09-10
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

MOTRIN · ReferenceDiscontinued
IBUPROFEN 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2007-09-10Labeling · Supplement 20 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 19 · standard — Label ↗AP
2002-02-04Labeling · Supplement 13 · standard — Review ↗AP
2001-05-14Manufacturing (CMC) · Supplement 16 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 15 · standardAP
1996-02-22Manufacturing (CMC) · Supplement 11 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 10 · standardAP
1995-06-23Manufacturing (CMC) · Supplement 6 · standardAP
1995-06-23Manufacturing (CMC) · Supplement 9 · standardAP
1995-06-23Manufacturing (CMC) · Supplement 7 · standardAP
1995-03-24Efficacy · Supplement 4 · standardAP
1994-06-13Manufacturing (CMC) · Supplement 5 · standardAP
1993-03-23Labeling · Supplement 3 · standardAP
1989-09-19Type 5 - New Formulation or New Manufacturer · 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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