bendamustine hydrochloride
bendamustine hydrochloride is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Bendeka, bendamustine hydrochloride, BENDAMUSTINE HYDROCHLORIDE. Available dosage forms: powder, injection, solution, injection, powder, lyophilized, for solution, injection.
Drug Details
- Generic Name
- bendamustine hydrochloride
- Brand Names
- Bendeka, bendamustine hydrochloride, BENDAMUSTINE HYDROCHLORIDE, BELRAPZO
- Application Number
- NDA208194
- Sponsor
- NATCO PHARMA LIMITED
- NDC Codes
- 8
- Dosage Forms
- POWDER, INJECTION, SOLUTION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- BENDAMUSTINE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Bendamustine hydrochloride for injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regime n.