FDA.reportPublic FDA data

Application 208462

Type
NDA
Sponsor
MILLENNIUM PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 2.3MG BASEYesNo
002NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 3MG BASEYesNo
003NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 4MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63020-078NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-078NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-078NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-079NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-079NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-079NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-080NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-080NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-080NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-230NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-230NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-230NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-230NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-230NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-230NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-230NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-390NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-390NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-390NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-390NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-390NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-390NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-390NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-400NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-400NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-400NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-400NINLAROixazomibMillennium Pharmaceuticals, Inc.NDACurrent
63020-400NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-400NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent
63020-400NINLAROixazomibTakeda Pharmaceuticals America, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78982SUPPL 2024-07-05
78959SUPPL 2024-07-02
77704SUPPL 2024-03-04
77691SUPPL 2024-03-04
70856SUPPL2022-04-29
70855SUPPL2022-04-29
66740SUPPL2021-03-11
66739SUPPL2021-03-11
64579SUPPL2020-09-15
64578SUPPL2020-09-15
64563SUPPL2020-09-11
64562SUPPL2020-09-11
61981SUPPL2020-02-27
61956SUPPL2020-02-25
45998SUPPL2016-12-01
45956SUPPL2016-11-25
43548ORIG2015-12-30
44976ORIG2015-12-01
40634ORIG2015-11-20
10656ORIG2015-11-20