Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204623
Company: HZNP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENNSAID DICLOFENAC SODIUM 2% SOLUTION;TOPICAL Prescription 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
01/16/2014 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/2014/204623s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204623Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/09/2016 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204623Orig1s005ltr.pdf
05/06/2015 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/2014 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204623Orig1s003ltr.pdf
07/10/2014 SUPPL-2 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf
07/21/2014 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-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
05/09/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
05/09/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204623s005lbl.pdf
11/05/2014 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s003lbl.pdf
07/10/2014 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s002lbl.pdf
01/16/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204623s000lbl.pdf

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