Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216490

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YORVIPATH (PALOPEGTERIPARATIDE)
EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)
Marketing Status: Prescription

Active Ingredient: PALOPEGTERIPARATIDE
Proprietary Name: YORVIPATH
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216490
Product Number: 001
Approval Date: Aug 9, 2024
Applicant Holder Full Name: ASCENDIS PHARMA BONE DISEASES AS
Marketing Status:  Prescription
Patent and Exclusivity Information

YORVIPATH (PALOPEGTERIPARATIDE)
EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)
Marketing Status: Prescription

Active Ingredient: PALOPEGTERIPARATIDE
Proprietary Name: YORVIPATH
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216490
Product Number: 002
Approval Date: Aug 9, 2024
Applicant Holder Full Name: ASCENDIS PHARMA BONE DISEASES AS
Marketing Status:  Prescription
Patent and Exclusivity Information

YORVIPATH (PALOPEGTERIPARATIDE)
EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)
Marketing Status: Prescription

Active Ingredient: PALOPEGTERIPARATIDE
Proprietary Name: YORVIPATH
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216490
Product Number: 003
Approval Date: Aug 9, 2024
Applicant Holder Full Name: ASCENDIS PHARMA BONE DISEASES AS
Marketing Status:  Prescription
Patent and Exclusivity Information