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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075168
Company: DR REDDYS LABS INC

Products on ANDA 075168

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 075168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75168ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2010	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
07/10/2009	SUPPL-8	Labeling		Label is not available on this site.
03/16/2008	SUPPL-5	Labeling		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	074661	PERRIGO
NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET;ORAL	Over-the-counter	No	212033	YICHANG HUMANWELL

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