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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201153
Company: GRACEWAY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYCLARA IMIQUIMOD 3.75% CREAM; TOPICAL Prescription None No 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
03/24/2011 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153_zyclara_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201153Orig1s000SumR.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/24/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201153s000,022483s001lbl.pdf
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