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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020310

NIZORAL ANTI-DANDRUFF (KETOCONAZOLE)
1%
Marketing Status: Over-the-counter
Active Ingredient: KETOCONAZOLE
Proprietary Name: NIZORAL ANTI-DANDRUFF
Dosage Form; Route of Administration: SHAMPOO; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020310
Product Number: 001
Approval Date: Oct 10, 1997
Applicant Holder Full Name: KRAMER LABORATORIES INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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