Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074201
Company: TEVA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/1993 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
07/13/2015 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/13/2015 SUPPL-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/13/2015 SUPPL-38 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/28/2008 SUPPL-31 Labeling

Label is not available on this site.

03/11/2009 SUPPL-30 Labeling

Label is not available on this site.

02/17/2006 SUPPL-26 Labeling

Label is not available on this site.

10/22/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2000 SUPPL-16 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/28/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/29/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1996 SUPPL-3 Labeling

Label is not available on this site.

01/27/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/21/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 LTD
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 250MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
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 LTD
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
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 LTD
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 077339 PERRIGO R AND D
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074201 TEVA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078620 ZYDUS PHARMS USA

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