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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203567
Company: BAUSCH

Summary Review

Products on NDA 203567

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JUBLIA	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203567

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/06/2014	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/2014/203567s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203567Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203567s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203567Orig1s010ltr.pdf
04/26/2020	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203567s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203567Orig1s009ltr.pdf
09/22/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203567Orig1s006ltr.pdf
04/01/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/05/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/26/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/27/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf

Labels for NDA 203567

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203567s010lbl.pdf
04/26/2020	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203567s009lbl.pdf
09/22/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf
02/27/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf
06/06/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf

Therapeutic Equivalents for NDA 203567

JUBLIA

SOLUTION;TOPICAL; 10%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	211969	NIVAGEN PHARMS INC
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	211827	TEVA PHARMS USA
JUBLIA	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	Yes	AB	203567	BAUSCH

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