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FDA NDA · NDA201803

ADVIL

ibuprofen sodium

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA201803
TYPE
NDA
ORIGINAL APPROVAL
2012-06-12
LATEST ACTION
2022-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL · ReferenceOver-the-counter
IBUPROFEN SODIUM EQ 200MG BASE · TABLET · ORAL

Approval history

2022-02-08Labeling · Supplement 16 · standard — Letter ↗AP
2018-05-31Labeling · Supplement 12 · standard — Letter ↗AP
2018-04-12Labeling · Supplement 11 · standard — Letter ↗AP
2017-08-22Labeling · Supplement 9 · standard — Label ↗AP
2017-06-12Labeling · Supplement 8 · standard — Letter ↗AP
2016-06-03Labeling · Supplement 7 · standard — Label ↗AP
2015-11-05Manufacturing (CMC) · Supplement 6 · standardAP
2014-01-03Manufacturing (CMC) · Supplement 3 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 1 · standardAP
2012-06-12Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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