Application 203560

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL125MGNoNo
002DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL250MGNoNo
003DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-454DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-455DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent
45963-456DeferasiroxDeferasiroxActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40310ORIG2016-03-18
10231ORIG2016-03-18