← FDA DRUG APPROVALS

FDA NDA · NDA021394

ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED

advil pm

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021394
TYPE
NDA
ORIGINAL APPROVAL
2005-12-21
LATEST ACTION
2023-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ADVIL PM · ReferenceOver-the-counter
DIPHENHYDRAMINE CITRATE 38MG, IBUPROFEN 200MG · TABLET · ORAL

Approval history

2023-02-21Labeling · Supplement 33 · standard — Letter ↗AP
2022-01-10Labeling · Supplement 32 · standard — Label ↗AP
2018-10-02Labeling · Supplement 26 · standard — Label ↗AP
2018-04-18Labeling · Supplement 25 · standard — Letter ↗AP
2017-07-21Labeling · Supplement 23 · standard — Letter ↗AP
2017-03-30Labeling · Supplement 21 · standard — Letter ↗AP
2016-03-15Manufacturing (CMC) · Supplement 20 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 18 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 19 · standardAP
2011-04-25Labeling · Supplement 14 · standard — Letter ↗AP
2010-09-01Labeling · Supplement 15 · standard — Letter ↗AP
2009-05-19Labeling · Supplement 12 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 10 · standard — Letter ↗AP
2005-12-21Type 4 - New Combination · Original · standard — Review ↗AP
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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