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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206488

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EXONDYS 51 (ETEPLIRSEN)
100MG/2ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: ETEPLIRSEN
Proprietary Name: EXONDYS 51
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/2ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206488
Product Number: 001
Approval Date: Sep 19, 2016
Applicant Holder Full Name: SAREPTA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
EXONDYS 51 (ETEPLIRSEN)
500MG/10ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: ETEPLIRSEN
Proprietary Name: EXONDYS 51
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 500MG/10ML (50MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206488
Product Number: 002
Approval Date: Sep 19, 2016
Applicant Holder Full Name: SAREPTA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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