Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209531

SPINRAZA (NUSINERSEN SODIUM)
12MG/5ML (2.4MG/ML) Marketing Status: Prescription

Active Ingredient: NUSINERSEN SODIUM
Proprietary Name: SPINRAZA
Dosage Form; Route of Administration: SOLUTION; INTRATHECAL
Strength: 12MG/5ML (2.4MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209531
Product Number: 001
Approval Date: Dec 23, 2016
Applicant Holder Full Name: BIOGEN IDEC INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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