Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074140
Company: GRANULES
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
10/29/2008 SUPPL-31 Labeling

Label is not available on this site.

04/29/2008 SUPPL-28 Labeling

Label is not available on this site.

11/28/2007 SUPPL-27 Labeling

Label is not available on this site.

07/15/2007 SUPPL-26 Labeling

Label is not available on this site.

03/25/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

10/05/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/14/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/17/2000 SUPPL-8 Labeling

Label is not available on this site.

08/17/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/22/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/01/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/05/1995 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 074140 GRANULES
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 077339 PERRIGO PHARMS CO
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 LTD
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 375MG TABLET;ORAL Prescription No AB 074140 GRANULES
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 077339 PERRIGO PHARMS CO
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 LTD
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074140 GRANULES
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 077339 PERRIGO PHARMS CO
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

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