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FDA ANDA · ANDA208499

CAREONE NAPROXEN SODIUM PM

diphenhydramine hydrochloride, naproxen sodium

Sponsor: PERRIGO R AND D

APPLICATION
ANDA208499
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-10
LATEST ACTION
2023-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEOver-the-counter
DIPHENHYDRAMINE HYDROCHLORIDE 25MG, NAPROXEN SODIUM 220MG · TABLET · ORAL

Approval history

2023-10-04Labeling · Supplement 6 · standardAP
2023-10-04Labeling · Supplement 10 · standardAP
2019-05-10UNKNOWN · Original · standardAP
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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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