FDA.reportPublic FDA data

Application 203567

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JUBLIAEFINACONAZOLESOLUTION;TOPICAL10%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5400JUBLIAefinaconazoleValeant Pharmaceuticals North America LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleValeant Pharmaceuticals North America LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent
0187-5400JUBLIAefinaconazoleBausch Health US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70689SUPPL2022-04-05
70681SUPPL2022-04-04
62691SUPPL2020-04-27
62685SUPPL2020-04-27
45525SUPPL2016-10-12
45388SUPPL2016-09-27
19483SUPPL2015-03-20
32443SUPPL2015-03-02
24439ORIG2014-07-03
43439ORIG2014-07-02
32442ORIG2014-06-10
19482ORIG2014-06-10