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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211728

Marketing Status: Prescription
Active Ingredient: MITOMYCIN
Proprietary Name: JELMYTO
Dosage Form; Route of Administration: POWDER; PYELOCALYCEAL
Strength: 40MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211728
Product Number: 001
Approval Date: Apr 15, 2020
Applicant Holder Full Name: UROGEN PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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