Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074661
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter None 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
01/13/1997 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
10/25/2014 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

10/25/2014 SUPPL-58 Labeling-Container/Carton Labels

Label is not available on this site.

10/25/2014 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

01/19/2012 SUPPL-44 Labeling-Container/Carton Labels

Label is not available on this site.

09/07/2010 SUPPL-43 Labeling

Label is not available on this site.

11/12/2014 SUPPL-40 Labeling

Label is not available on this site.

12/19/2006 SUPPL-28 Labeling

Label is not available on this site.

03/13/2006 SUPPL-27 Labeling

Label is not available on this site.

11/20/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

12/10/2001 SUPPL-8 Labeling

Label is not available on this site.

08/25/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/19/1999 SUPPL-4 Labeling

Label is not available on this site.

08/28/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; EQ 200MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALEVE NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter Yes 020204 BAYER
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 079096 AMNEAL PHARMS NY
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 205497 AUROBINDO PHARMA LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 074635 CONTRACT PHARMACAL
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 075168 DR REDDYS LABS INC
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 091353 GRANULES INDIA
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 204872 LNK INTL INC
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 090545 MARKSANS PHARMA
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 207612 NOVELGENIX THERAPS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 074661 PERRIGO
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 091183 SUN PHARM INDS LTD

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