Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208325

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PARSABIV (ETELCALCETIDE)
2.5MG/0.5ML (2.5MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: ETELCALCETIDE
Proprietary Name: PARSABIV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2.5MG/0.5ML (2.5MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208325
Product Number: 001
Approval Date: Feb 7, 2017
Applicant Holder Full Name: KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PARSABIV (ETELCALCETIDE)
5MG/ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: ETELCALCETIDE
Proprietary Name: PARSABIV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208325
Product Number: 002
Approval Date: Feb 7, 2017
Applicant Holder Full Name: KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PARSABIV (ETELCALCETIDE)
10MG/2ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: ETELCALCETIDE
Proprietary Name: PARSABIV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208325
Product Number: 003
Approval Date: Feb 7, 2017
Applicant Holder Full Name: KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information