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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206255

Marketing Status: Prescription
Active Ingredient: IVERMECTIN
Proprietary Name: SOOLANTRA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N206255
Product Number: 001
Approval Date: Dec 19, 2014
Applicant Holder Full Name: GALDERMA LABORATORIES LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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