An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090545
Company: MARKSANS PHARMA

Products on ANDA 090545

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 090545

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2011	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
07/21/2023	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/21/2023	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/21/2023	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		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

Top