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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212209


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NDA 212209 describes VIVIMUSTA, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VIVIMUSTA profile page.

The generic ingredient in VIVIMUSTA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 212209
Tradename:VIVIMUSTA
Applicant:Azurity
Ingredient:bendamustine hydrochloride
Patents:1
Pharmacology for NDA: 212209
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 212209
Suppliers and Packaging for NDA: 212209
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIVIMUSTA bendamustine hydrochloride SOLUTION;INTRAVENOUS 212209 NDA Slayback Pharma LLC 71225-120 71225-120-01 1 VIAL, MULTI-DOSE in 1 CARTON (71225-120-01) / 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/4ML (25MG/ML)
Approval Date:Dec 7, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 29, 2042Product Flag?YSubstance Flag?Delist Request?

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