FDA.reportPublic FDA data

Application 209223

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3515DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3516DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3516DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3516DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3516DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3516DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3517DeferasiroxDeferasiroxTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61190ORIG2019-11-25
61189ORIG2019-11-25