Product Details for NDA 202714
KYPROLIS (CARFILZOMIB)
10MG/VIAL
Marketing Status: Prescription
30MG/VIAL
Marketing Status: Prescription
60MG/VIAL
Marketing Status: Prescription
10MG/VIAL
Marketing Status: Prescription
Active Ingredient: CARFILZOMIB
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 10MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202714
Product Number: 003
Approval Date: Jun 7, 2018
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information
KYPROLIS (CARFILZOMIB)
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 10MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202714
Product Number: 003
Approval Date: Jun 7, 2018
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG/VIAL
Marketing Status: Prescription
Active Ingredient: CARFILZOMIB
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 30MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202714
Product Number: 002
Approval Date: Jun 3, 2016
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information
KYPROLIS (CARFILZOMIB)
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 30MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202714
Product Number: 002
Approval Date: Jun 3, 2016
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information
60MG/VIAL
Marketing Status: Prescription
Active Ingredient: CARFILZOMIB
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 60MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202714
Product Number: 001
Approval Date: Jul 20, 2012
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: KYPROLIS
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 60MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N202714
Product Number: 001
Approval Date: Jul 20, 2012
Applicant Holder Full Name: ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status: Prescription
Patent and Exclusivity Information