FDA.reportPublic FDA data

Application 202714

Type
NDA
Sponsor
ONYX THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KYPROLISCARFILZOMIBPOWDER;INTRAVENOUS60MG/VIALYesYes
002KYPROLISCARFILZOMIBPOWDER;INTRAVENOUS30MG/VIALYesNo
003KYPROLISCARFILZOMIBPOWDER;INTRAVENOUS10MG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-101KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-102KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent
76075-103KYPROLIScarfilzomibOnyx Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82410SUPPL 2025-06-02
82314SUPPL 2025-05-27
71506SUPPL2022-07-05
71505SUPPL2022-07-01
69434SUPPL2021-12-01
69430SUPPL2021-12-01
66741SUPPL2021-03-11
66709SUPPL2021-03-10
64379SUPPL2020-08-24
64333SUPPL2020-08-20
62882SUPPL2020-05-11
62879SUPPL2020-05-08
60453SUPPL2019-10-09
60254SUPPL2019-10-07
57872SUPPL2019-03-01
57863SUPPL2019-03-01
57349SUPPL2019-01-28
55793SUPPL2018-10-03
55770SUPPL2018-10-01
54558SUPPL2018-06-14
54493SUPPL2018-06-11
51091SUPPL2018-01-18
51076SUPPL2018-01-17
48563SUPPL2017-05-30
48559SUPPL2017-05-30
45986SUPPL2016-12-01
45908SUPPL2016-11-18
44998SUPPL2016-08-04
44986SUPPL2016-08-04
19370SUPPL2016-07-06
10097SUPPL2016-07-06
40209SUPPL2016-05-25
10096SUPPL2016-05-25
40208SUPPL2016-01-26
32291SUPPL2016-01-22
32290SUPPL2015-07-27
40207SUPPL2015-07-24
19369SUPPL2015-04-07
32289SUPPL2015-04-03
44863ORIG2012-08-20
43410ORIG2012-08-20
32288ORIG2012-07-20
19368ORIG2012-07-20