Application 211882

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARAZLOTAZAROTENELOTION;TOPICAL0.045%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-2098ArazlotazaroteneBausch Health US, LLCNDACurrent
0187-2098ArazlotazaroteneBausch Health US LLCNDACurrent
0187-2098ArazlotazaroteneBausch Health US, LLCNDACurrent
0187-2098ArazlotazaroteneBausch Health US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63844ORIG2020-07-10
61365ORIG2019-12-20
61350ORIG2019-12-19
63246ORIG1900-01-01