U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 209531

SPINRAZA (NUSINERSEN SODIUM)
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: NUSINERSEN SODIUM
Proprietary Name: SPINRAZA
Dosage Form; Route of Administration: SOLUTION; INTRATHECAL
Strength: EQ 12MG BASE/5ML (EQ 2.4MG BASE/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
Back to Top