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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208901

TOLSURA (ITRACONAZOLE)
65MG
Marketing Status: Prescription
Active Ingredient: ITRACONAZOLE
Proprietary Name: TOLSURA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 65MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208901
Product Number: 001
Approval Date: Dec 11, 2018
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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