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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208499
Company: PERRIGO R AND D

Products on ANDA 208499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2023	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
10/04/2023	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 25MG;220MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALEVE PM	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	Yes	205352	BAYER HLTHCARE
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	No	209726	AMNEAL PHARMS CO
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	No	211830	COREPHARMA
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	No	213663	GRANULES
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET;ORAL	Over-the-counter	No	208499	PERRIGO R AND D

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