Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078250
Company: GLENMARK PHARMS LTD

Products on ANDA 078250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	AB	No	No
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	AB	No	No
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2007	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-18	Labeling-Package Insert		Label is not available on this site.
07/28/2020	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/28/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/13/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/08/2011	SUPPL-8	Labeling		Label is not available on this site.
09/08/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078250

NAPROXEN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	091416	ADAPTIS
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	075927	AMNEAL PHARMS NY
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	200429	AUROBINDO PHARMA
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	078250	GLENMARK PHARMS LTD
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	074140	GRANULES
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	212517	SCIEGEN PHARMS INC
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	074201	TEVA
NAPROXEN	NAPROXEN	250MG	TABLET;ORAL	Prescription	No	AB	078620	ZYDUS PHARMS USA

TABLET;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	091416	ADAPTIS
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	075927	AMNEAL PHARMS NY
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	200429	AUROBINDO PHARMA
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	078250	GLENMARK PHARMS LTD
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	074140	GRANULES
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	212517	SCIEGEN PHARMS INC
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	074201	TEVA
NAPROXEN	NAPROXEN	375MG	TABLET;ORAL	Prescription	No	AB	078620	ZYDUS PHARMS USA

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROSYN	NAPROXEN	500MG	TABLET;ORAL	Prescription	Yes	AB	017581	ATNAHS PHARMA US
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	091416	ADAPTIS
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	075927	AMNEAL PHARMS NY
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	200429	AUROBINDO PHARMA
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	078250	GLENMARK PHARMS LTD
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	074140	GRANULES
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	212517	SCIEGEN PHARMS INC
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	074201	TEVA
NAPROXEN	NAPROXEN	500MG	TABLET;ORAL	Prescription	No	AB	078620	ZYDUS PHARMS USA