← FDA DRUG APPROVALS

FDA NDA · NDA021393

ADVIL PM

diphenhydramine hcl, ibuprofen

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021393
TYPE
NDA
ORIGINAL APPROVAL
2005-12-21
LATEST ACTION
2024-09-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

ADVIL PM · ReferenceOver-the-counter
DIPHENHYDRAMINE HYDROCHLORIDE 25MG, IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL

Approval history

2024-09-09Manufacturing (CMC) · Supplement 22 — Label ↗AP
2022-01-11Labeling · Supplement 21 · standard — Label ↗AP
2018-05-07Labeling · Supplement 17 · standard — Letter ↗AP
2017-03-29Labeling · Supplement 14 · standard — Letter ↗AP
2013-02-04Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2011-04-20Labeling · Supplement 7 · unknown — Letter ↗AP
2009-05-19Labeling · Supplement 6 · standard — Letter ↗AP
2008-06-11Labeling · Supplement 5 · 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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