Application 208697

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET;ORAL90MGNoNo
002DEFERASIROXDEFERASIROXTABLET;ORAL180MGNoNo
003DEFERASIROXDEFERASIROXTABLET;ORAL360MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3853DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
0591-3853DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
0591-3853DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62172ORIG2020-03-17