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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212209

VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE)
100MG/4ML (25MG/ML)
Marketing Status: Prescription
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE
Proprietary Name: VIVIMUSTA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100MG/4ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212209
Product Number: 001
Approval Date: Dec 7, 2022
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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