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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078314
Company: GLENMARK PHARMS LTD

Other Important Information from FDA

Products on ANDA 078314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	AB	No	No
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2007	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
07/28/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/28/2020	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/28/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/08/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078314

NAPROXEN SODIUM

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078432	AMNEAL PHARMS NY
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	200629	AUROBINDO PHARMA LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078486	DR REDDYS LABS LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	078314	GLENMARK PHARMS LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	212199	SCIEGEN PHARMS INC

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANAPROX DS	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	Yes	AB	018164	ATNAHS PHARMA US
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	078432	AMNEAL PHARMS NY
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	200629	AUROBINDO PHARMA LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	078486	DR REDDYS LABS LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	078314	GLENMARK PHARMS LTD
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	212199	SCIEGEN PHARMS INC

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