FDA NDA · NDA020603

INFANTS MOTRIN

ibuprofen

Sponsor: KENVUE BRANDS

APPLICATION

NDA020603

TYPE

NDA

ORIGINAL APPROVAL

1996-06-10

LATEST ACTION

2017-03-16

ROUTE

ORAL

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Over-the-counter

Products

CHILDREN'S MOTRIN · ReferenceOver-the-counter

IBUPROFEN 40MG/ML · SUSPENSION/DROPS · ORAL

2017-03-16Labeling · Supplement 22 · standard — Label ↗AP

2016-08-29Labeling · Supplement 21 · standard — Label ↗AP

2015-12-04Manufacturing (CMC) · Supplement 18 · standardAP

2010-07-15Labeling · Supplement 14 · unknown — Letter ↗AP

2009-04-29Labeling · Supplement 13 · standard — Letter ↗AP

2006-02-27Labeling · Supplement 11 · standard — Letter ↗AP

2002-01-16Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP

2001-05-03Manufacturing (CMC) · Supplement 4 · standardAP

1999-09-13Labeling · Supplement 2 · standard — Review ↗AP

1999-04-15Efficacy · Supplement 3 · standard — Review ↗AP

1998-06-12Labeling · Supplement 1 · standard — Review ↗AP

1996-06-10Type 3 - New Dosage Form · Original · standardAP

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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