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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203568

200MG/ML (200MG/ML)
Marketing Status: Discontinued
Active Ingredient: MIPOMERSEN SODIUM
Proprietary Name: KYNAMRO
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 200MG/ML (200MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203568
Product Number: 001
Approval Date: Jan 29, 2013
Applicant Holder Full Name: KASTLE THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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