Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020254
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOLTAREN-XR DICLOFENAC SODIUM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
03/08/1996 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
05/09/2016 SUPPL-28 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf
06/05/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/28/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/25/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/23/2011 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf
02/23/2011 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf
02/25/2009 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf
01/24/2006 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020254Orig1s016.pdf
09/19/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/05/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/13/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/18/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/22/1999 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/11/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2001 SUPPL-2 Labeling

Label is not available on this site.

05/21/1996 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
05/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf
05/09/2016 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf
05/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020254s028lbl.pdf
02/23/2011 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf
02/23/2011 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020254s019s020lbl.pdf
02/25/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020254s018.pdf
01/24/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020254s016lbl.pdf

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