Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075927
Company: AMNEAL PHARMS NY

Products on ANDA 075927

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 075927

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2001	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
11/22/2019	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
11/22/2019	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/02/2014	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/16/2007	SUPPL-11	Labeling		Label is not available on this site.
05/19/2006	SUPPL-6	Labeling		Label is not available on this site.
11/20/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075927

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	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	091416	MARKSANS PHARMA
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	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	091416	MARKSANS PHARMA
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	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	091416	MARKSANS PHARMA
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