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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210922

ONPATTRO (PATISIRAN SODIUM)
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: PATISIRAN SODIUM
Proprietary Name: ONPATTRO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210922
Product Number: 001
Approval Date: Aug 10, 2018
Applicant Holder Full Name: ALNYLAM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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