Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202714

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KYPROLIS (CARFILZOMIB)
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 THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KYPROLIS (CARFILZOMIB)
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 THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KYPROLIS (CARFILZOMIB)
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: 
Application Number: N202714
Product Number: 001
Approval Date: Jul 20, 2012
Applicant Holder Full Name: ONYX THERAPEUTICS INC A WHOLLY OWNED SUB OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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