Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020204
Company: BAYER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALEVE NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/11/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2017 SUPPL-52 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s052ltr.pdf
08/22/2017 SUPPL-51 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s051ltr.pdf
07/28/2016 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/25/2016 SUPPL-48 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf
02/04/2015 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

04/18/2013 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s044ltr.pdf
01/07/2013 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/03/2013 SUPPL-42 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s042ltr.pdf
11/13/2012 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/16/2012 SUPPL-40 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204s40ltr.pdf
03/15/2012 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204Orig1s039ltr.pdf
02/07/2013 SUPPL-38 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s038ltr.pdf
04/08/2011 SUPPL-37 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s037ltr.pdf
02/18/2011 SUPPL-36 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s036ltr.pdf
11/03/2010 SUPPL-35 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020204s035ltr.pdf
04/15/2009 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020204s032ltr.pdf
11/24/2008 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020204s031ltr.pdf
01/06/2006 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf
05/04/2005 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020204s021ltr.pdf
03/22/2004 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20204slr019ltr.pdf
08/30/2002 SUPPL-16 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204scm016ltr.pdf
12/21/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/03/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/07/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/11/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/23/2000 SUPPL-10 Labeling

Label is not available on this site.

03/19/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204s8ltr.pdf
03/06/2001 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20204S7LTR.PDF
11/20/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1998 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/01/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2017 SUPPL-52 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s052lbl.pdf
08/22/2017 SUPPL-51 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s051lbl.pdf
02/25/2016 SUPPL-48 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf
04/18/2013 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf
02/07/2013 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf
05/04/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf

ALEVE

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 074789 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 074661 PERRIGO
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 091183 SUN PHARM INDS LTD

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