An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	211827	TEVA PHARMS USA
EFINACONAZOLE	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	No	AB	211969	UMEDICA
JUBLIA	EFINACONAZOLE	10%	SOLUTION;TOPICAL	Prescription	Yes	AB	203567	BAUSCH

Top