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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204684

IMPAVIDO (MILTEFOSINE)
50MG
Marketing Status: Prescription
Active Ingredient: MILTEFOSINE
Proprietary Name: IMPAVIDO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204684
Product Number: 001
Approval Date: Mar 19, 2014
Applicant Holder Full Name: KNIGHT THERAPEUTICS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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