Details for New Drug Application (NDA): 215033
✉ Email this page to a colleague
The generic ingredient in BENDAMUSTINE HYDROCHLORIDE 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 215033
Tradename: | BENDAMUSTINE HYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | bendamustine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215033
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 215033
Suppliers and Packaging for NDA: 215033
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 215033 | NDA | Apotex Corp | 60505-6228 | 60505-6228-0 | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 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: | AP | RLD: | Yes |
Complete Access Available with Subscription