Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022259

Marketing Status: Prescription
Active Ingredient: FLUOROURACIL
Proprietary Name: TOLAK
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 4%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022259
Product Number: 001
Approval Date: Sep 18, 2015
Applicant Holder Full Name: HILL DERMACEUTICALS INC
Marketing Status:  Prescription
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