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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020947
Company: NUVO PHARMS INC

Medication Guide

Summary Review

Products on NDA 020947

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PENNSAID	DICLOFENAC SODIUM	1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020947

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

Labels for NDA 020947

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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