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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 070767

NIZORAL (KETOCONAZOLE)
100MG/5ML
Marketing Status: Discontinued
Active Ingredient: KETOCONAZOLE
Proprietary Name: NIZORAL
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A070767
Product Number: 001
Approval Date: Nov 7, 1986
Applicant Holder Full Name: JANSSEN PHARMACEUTICA PRODUCTS LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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