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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022572

Marketing Status: Prescription
Active Ingredient: MITOMYCIN
Proprietary Name: MITOSOL
Dosage Form; Route of Administration: FOR SOLUTION; TOPICAL
Strength: 0.2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022572
Product Number: 001
Approval Date: Feb 7, 2012
Applicant Holder Full Name: MOBIUS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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