Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022129
Company: SHIONOGI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULESFIA BENZYL ALCOHOL 5% LOTION;TOPICAL Discontinued None Yes 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
04/09/2009 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/2009/022129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022129s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022129s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2020 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022129s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022129Orig1s008ltr.pdf
03/24/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/12/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022129s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022129Orig1s005ltr.pdf
06/22/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022129s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022129s002ltr.pdf
02/03/2010 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/26/2020 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022129s008lbl.pdf
07/12/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022129s005lbl.pdf
06/22/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022129s002lbl.pdf
04/09/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022129lbl.pdf

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