Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200629
Company: AUROBINDO PHARMA LTD
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
10/31/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2015 SUPPL-3 Labeling-Package Insert

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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