FDA.reportPublic FDA data

Application 209355

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRYHALIHALOBETASOL PROPIONATELOTION;TOPICAL0.01%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0002Bryhalihalobetasol propionateBausch Health US, LLCNDACurrent
0187-0002Bryhalihalobetasol propionateBausch Health Americas Inc.NDACurrent
0187-0002Bryhalihalobetasol propionateValeant Pharmaceuticals North America LLCNDACurrent
0187-0002Bryhalihalobetasol propionateBausch Health US, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57038ORIG2018-12-26
55935ORIG2018-11-15
56361ORIG2018-11-08