Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212194

GIVLAARI (GIVOSIRAN SODIUM)
EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: GIVOSIRAN SODIUM
Proprietary Name: GIVLAARI
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212194
Product Number: 001
Approval Date: Nov 20, 2019
Applicant Holder Full Name: ALNYLAM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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