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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204153
Company: BAUSCH

Summary Review

Products on NDA 204153

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUZU	LULICONAZOLE	1%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204153

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.

Labels for NDA 204153

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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