Details for New Drug Application (NDA): 212209
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NDA 212209 describes VIVIMUSTA, which is a drug marketed by Slayback Pharma Llc 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. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
The generic ingredient in VIVIMUSTA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 212209
| Tradename: | VIVIMUSTA |
| Applicant: | Slayback Pharma Llc |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Jul 29, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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