Details for New Drug Application (NDA): 212209
✉ Email this page to a colleague
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 Action | Alkylating 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/4ML (25MG/ML) | ||||
Approval Date: | Dec 7, 2022 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 29, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? |
Complete Access Available with Subscription