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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021307

LOTRIMIN ULTRA (BUTENAFINE HYDROCHLORIDE)
1%
Marketing Status: Over-the-counter
Active Ingredient: BUTENAFINE HYDROCHLORIDE
Proprietary Name: LOTRIMIN ULTRA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021307
Product Number: 001
Approval Date: Dec 7, 2001
Applicant Holder Full Name: BAYER HEALTHCARE LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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