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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021022

PENLAC (CICLOPIROX)
8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CICLOPIROX
Proprietary Name: PENLAC
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N021022
Product Number: 001
Approval Date: Dec 17, 1999
Applicant Holder Full Name: VALEANT INTERNATIONAL BERMUDA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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