FDA.reportPublic FDA data

Application 209354

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUOBRIIHALOBETASOL PROPIONATE; TAZAROTENELOTION;TOPICAL0.01%;0.045%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0653Duobriihalobetasol propionate and tazaroteneBausch Health US, LLCNDACurrent
0187-0653Duobriihalobetasol propionate and tazaroteneBausch Health US, LLCNDACurrent
0187-0653Duobriihalobetasol propionate and tazaroteneBausch Health US, LLCNDACurrent
0187-0653Duobriihalobetasol propionate and tazaroteneValeant Pharmaceuticals North America LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61551ORIG2020-01-10
58456ORIG2019-04-29
58442ORIG2019-04-26