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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022129
Company: SHIONOGI INC

Summary Review

Products on NDA 022129

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULESFIA	BENZYL ALCOHOL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022129

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.

Labels for NDA 022129

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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