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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211970

100MG/2ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: GOLODIRSEN
Proprietary Name: VYONDYS 53
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/2ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211970
Product Number: 001
Approval Date: Dec 12, 2019
Applicant Holder Full Name: SAREPTA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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