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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022129

ULESFIA (BENZYL ALCOHOL)
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BENZYL ALCOHOL
Proprietary Name: ULESFIA
Dosage Form; Route of Administration: LOTION; TOPICAL
Strength: 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022129
Product Number: 001
Approval Date: Apr 9, 2009
Applicant Holder Full Name: SHIONOGI INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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