Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215842

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RIVFLOZA (NEDOSIRAN SODIUM)
EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NEDOSIRAN SODIUM
Proprietary Name: RIVFLOZA
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215842
Product Number: 001
Approval Date: Sep 29, 2023
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RIVFLOZA (NEDOSIRAN SODIUM)
EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NEDOSIRAN SODIUM
Proprietary Name: RIVFLOZA
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215842
Product Number: 002
Approval Date: Sep 29, 2023
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RIVFLOZA (NEDOSIRAN SODIUM)
EQ 160MG BASE/ML (EQ 160MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NEDOSIRAN SODIUM
Proprietary Name: RIVFLOZA
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: EQ 160MG BASE/ML (EQ 160MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215842
Product Number: 003
Approval Date: Sep 29, 2023
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information