Manufacturing Establishments (2)
Geneva Laboratories, Inc.
Onyx Pharmaceuticals, Inc.
091791129
Amgen Technology (ireland) Unlimited Company
Onyx Pharmaceuticals, Inc.
896293920
Products (3)
KYPROLIS
76075-102
NDA202714
NDA (C73594)
INTRAVENOUS
June 30, 2022
CarfilzomibActive
Code: 72X6E3J5ARClass: ACTIBQuantity: 30 mg in 15 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
KYPROLIS
76075-103
NDA202714
NDA (C73594)
INTRAVENOUS
June 30, 2022
CarfilzomibActive
Code: 72X6E3J5ARClass: ACTIBQuantity: 10 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
KYPROLIS
76075-101
NDA202714
NDA (C73594)
INTRAVENOUS
June 30, 2022
CarfilzomibActive
Code: 72X6E3J5ARClass: ACTIBQuantity: 60 mg in 30 mL
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT