FDA.report

Application 208462

Type
NDA
Sponsor
MILLENNIUM PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 2.3MG BASEYesNo
002NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 3MG BASEYesNo
003NINLAROIXAZOMIB CITRATECAPSULE;ORALEQ 4MG BASEYesYes

NDC Listings For This Application

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

DocumentTitleSubmission typeSubmission no.Date
789820SUPPL 172024-07-05
789590SUPPL 172024-07-02
777040SUPPL 162024-03-04
776910SUPPL 162024-03-04
708560SUPPL122022-04-29
708550SUPPL132022-04-29
667400SUPPL102021-03-11
667390SUPPL102021-03-11
645790SUPPL72020-09-15
645780SUPPL82020-09-15
645630SUPPL82020-09-11
645620SUPPL72020-09-11
619810SUPPL62020-02-27
619560SUPPL62020-02-25
459980SUPPL12016-12-01
459560SUPPL12016-11-25
435480ORIG12015-12-30
449760ORIG12015-12-01
406340ORIG12015-11-20
106560ORIG12015-11-20