FDA.reportPublic FDA data

Application 209401

Type
NDA
Sponsor
CELATOR PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYXEOSCYTARABINE; DAUNORUBICINPOWDER;INTRAVENOUS100MG;44MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent
68727-745VYXEOS(daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84859SUPPL 2026-01-28
84849SUPPL 2026-01-28
72174SUPPL2022-09-28
72169SUPPL2022-09-28
66933SUPPL2021-03-31
66924SUPPL2021-03-30
61559SUPPL2020-01-14
53816ORIG2018-04-25
49243ORIG2017-08-04
49218ORIG2017-08-03