Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019201
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOLTAREN DICLOFENAC SODIUM 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No
VOLTAREN DICLOFENAC SODIUM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No
VOLTAREN DICLOFENAC SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No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
07/28/1988 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/09/2016 SUPPL-46 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019201Orig1s046ltr.pdf
06/05/2014 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/23/2011 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf
02/23/2011 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019201s039,s040ltr.pdf
02/25/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019201s038ltr.pdf
07/09/2007 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019201s036ltr.pdf
01/24/2006 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf
09/19/2002 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/2002 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/28/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2000 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/20/2000 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/09/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/16/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/11/1997 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2001 SUPPL-23 Labeling

Label is not available on this site.

04/20/1998 SUPPL-22 Labeling

Label is not available on this site.

12/22/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/28/1995 SUPPL-20 Labeling

Label is not available on this site.

11/02/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/26/2002 SUPPL-18 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19201slr018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-201s018_Voltaren.cfm
12/08/1994 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1993 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/21/1992 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1990 SUPPL-10 Labeling

Label is not available on this site.

02/12/1990 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1989 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/12/1991 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1988 SUPPL-4 Labeling

Label is not available on this site.

02/06/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019201s046lbl.pdf
02/23/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf
02/23/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019201s039s040lbl.pdf
02/25/2009 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019201s038lbl.pdf
07/09/2007 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019201s036lbl.pdf
01/24/2006 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019201s035lbl.pdf

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