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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074661
Company: PERRIGO

Products on ANDA 074661

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2014	SUPPL-62	Labeling-Package Insert		Label is not available on this site.
10/25/2014	SUPPL-58	Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2014	SUPPL-54	Labeling-Package Insert		Label is not available on this site.
01/19/2012	SUPPL-44	Labeling-Container/Carton Labels		Label is not available on this site.
09/07/2010	SUPPL-43	Labeling		Label is not available on this site.
11/12/2014	SUPPL-40	Labeling		Label is not available on this site.
12/19/2006	SUPPL-28	Labeling		Label is not available on this site.
03/13/2006	SUPPL-27	Labeling		Label is not available on this site.
11/20/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
12/10/2001	SUPPL-8	Labeling		Label is not available on this site.
08/25/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-4	Labeling		Label is not available on this site.
08/28/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/11/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

NAPROXEN SODIUM

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

TABLET;ORAL; 220MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ALEVE	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	Yes	020204	BAYER
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	079096	AMNEAL PHARMS NY
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	205497	AUROBINDO PHARMA LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	074635	CONTRACT PHARMACAL
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	075168	DR REDDYS LABS INC
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	091353	GRANULES INDIA
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	211065	HETERO LABS LTD V
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	204872	LNK INTL INC
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	090545	MARKSANS PHARMA
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	207612	NOVELGENIX THERAPS
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	074661	PERRIGO
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	212033	YICHANG HUMANWELL

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