Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209531

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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

SPINRAZA (NUSINERSEN SODIUM)
EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NUSINERSEN SODIUM
Proprietary Name: SPINRAZA
Dosage Form; Route of Administration: SOLUTION; INTRATHECAL
Strength: EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209531
Product Number: 002
Approval Date: Mar 27, 2026
Applicant Holder Full Name: BIOGEN IDEC INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SPINRAZA (NUSINERSEN SODIUM)
EQ 50MG BASE/5ML (EQ 10MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NUSINERSEN SODIUM
Proprietary Name: SPINRAZA
Dosage Form; Route of Administration: SOLUTION; INTRATHECAL
Strength: EQ 50MG BASE/5ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209531
Product Number: 003
Approval Date: Mar 27, 2026
Applicant Holder Full Name: BIOGEN IDEC INC
Marketing Status:  Prescription
Patent and Exclusivity Information