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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020083

SPORANOX (ITRACONAZOLE)
100MG
Marketing Status: Prescription
Active Ingredient: ITRACONAZOLE
Proprietary Name: SPORANOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020083
Product Number: 001
Approval Date: Sep 11, 1992
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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