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FDA NDA · NDA205352

ALEVE PM

diphenhydramine hydrochloride and naproxen sodium

Sponsor: BAYER HLTHCARE

APPLICATION
NDA205352
TYPE
NDA
ORIGINAL APPROVAL
2014-01-17
LATEST ACTION
2022-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

ALEVE PM · ReferenceOver-the-counter
DIPHENHYDRAMINE HYDROCHLORIDE 25MG, NAPROXEN SODIUM 220MG · TABLET · ORAL

Approval history

2022-02-08Labeling · Supplement 16 · standard — Label ↗AP
2020-10-30Labeling · Supplement 15 · standard — Letter ↗AP
2020-04-06Labeling · Supplement 14 · standard — Letter ↗AP
2019-04-10Labeling · Supplement 13 · standard — Letter ↗AP
2018-08-28Labeling · Supplement 11 · standard — Letter ↗AP
2018-01-16Labeling · Supplement 10 · standard — Letter ↗AP
2017-09-12Labeling · Supplement 9 · standard — Letter ↗AP
2015-12-23Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2015-10-28Labeling · Supplement 6 · standard — Label ↗AP
2015-08-14Labeling · Supplement 5 · standard — Label ↗AP
2015-07-15Labeling · Supplement 4 · standard — Letter ↗AP
2015-02-25Labeling · Supplement 3 · standard — Label ↗AP
2014-11-20Labeling · Supplement 2 · standard — Label ↗AP
2014-08-28Labeling · Supplement 1 · standard — Label ↗AP
2014-01-17Type 4 - New Combination · Original · standard — Summary Review ↗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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