Application 212188

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAVABOROLETAVABOROLESOLUTION;TOPICAL5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-467TavaboroleTavaboroleAlembic Pharmaceuticals, Inc.ANDACurrent
62332-467TavaboroleTavaboroleAlembic Pharmaceuticals, Inc.ANDACurrent
62332-467TavaboroleTavaboroleAlembic Pharmaceuticals, Inc.ANDACurrent
71589-010TAVABOROLETAVABOROLEAleor Dermaceuticals LimitedANDACurrent
71589-010TAVABOROLETAVABOROLEAleor Dermaceuticals LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64602ORIG2020-09-18