Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022483
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYCLARA IMIQUIMOD 3.75% CREAM;TOPICAL Prescription None Yes Yes
ZYCLARA IMIQUIMOD 2.5% CREAM;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
03/25/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022483s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483_zyclara_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/24/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/14/2012 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022483s006ltr.pdf
07/15/2011 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s003ltr.pdf
09/29/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022483s002ltr.pdf
03/24/2011 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201153s000,022483s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2012 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022483s006lbl.pdf
09/29/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s002lbl.pdf
07/15/2011 SUPPL-3 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022483s003lbl.pdf
03/24/2011 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf
03/25/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022483Orig1s000Lbl.pdf

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