Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020947
Company: NUVO PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENNSAID DICLOFENAC SODIUM 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;TOPICAL Discontinued None Yes No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
11/04/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020947lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020947s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947_pennsaid_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf
05/09/2016 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf
10/21/2013 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020947Orig1s008ltr.pdf
07/14/2011 SUPPL-7 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020947s007ltr.pdf
03/25/2010 SUPPL-2 REMS-Assessment, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf
03/25/2010 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf
05/09/2016 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf
10/21/2013 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020947s008lbl.pdf
10/21/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020947s008lbl.pdf
03/25/2010 SUPPL-2 REMS-Assessment Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf
03/25/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf
03/25/2010 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf
03/25/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf
11/04/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020947lbl.pdf

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