Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204153
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUZU LULICONAZOLE 1% 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
11/14/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204153Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2018 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf
02/20/2018 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf
02/08/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204153s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204153Orig1s002ltr.pdf
06/07/2016 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
02/20/2018 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf
02/20/2018 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf
02/08/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204153s002lbl.pdf
11/14/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf

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