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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214103

OXLUMO (LUMASIRAN SODIUM)
EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)
Marketing Status: Prescription
Active Ingredient: LUMASIRAN SODIUM
Proprietary Name: OXLUMO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214103
Product Number: 001
Approval Date: Nov 23, 2020
Applicant Holder Full Name: ALNYLAM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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