Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074198
Company: TEVA
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
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
04/15/2015 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/28/2008 SUPPL-30 Labeling

Label is not available on this site.

05/19/2006 SUPPL-28 Labeling

Label is not available on this site.

02/17/2006 SUPPL-27 Labeling

Label is not available on this site.

08/22/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/24/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 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.

02/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/15/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-2 Labeling

Label is not available on this site.

02/17/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 074198 TEVA

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 074198 TEVA

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