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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202292

Marketing Status: Prescription
Active Ingredient: CROFELEMER
Proprietary Name: MYTESI
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202292
Product Number: 001
Approval Date: Dec 31, 2012
Applicant Holder Full Name: NAPO PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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