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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215515

AMVUTTRA (VUTRISIRAN SODIUM)
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
Marketing Status: Prescription
Active Ingredient: VUTRISIRAN SODIUM
Proprietary Name: AMVUTTRA
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215515
Product Number: 001
Approval Date: Jun 13, 2022
Applicant Holder Full Name: ALNYLAM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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