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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213535

Marketing Status: Prescription
Active Ingredient: RISDIPLAM
Proprietary Name: EVRYSDI
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 0.75MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213535
Product Number: 001
Approval Date: Aug 7, 2020
Applicant Holder Full Name: GENENTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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