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Fludarabine

Generic Name
Fludarabine
Brand Names
Fludara
Drug Type
Small Molecule
Chemical Formula
C10H12FN5O4
CAS Number
21679-14-1
Unique Ingredient Identifier
P2K93U8740

Overview

Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.

Background

Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.

Indication

For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen

Associated Conditions

  • B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma refractory
  • Refractory Non-Hodgkin's lymphoma

FDA Approved Products

Fludarabine phosphate
Manufacturer:Actavis Pharma, Inc.
Route:INTRAVENOUS
Strength:50 mg in 2 mL
Approved: 2023/01/24
NDC:45963-609
Fludarabine Phosphate
Manufacturer:Teva Pharmaceuticals, Inc.
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2023/07/25
NDC:0480-9772
Fludarabine Phosphate
Manufacturer:Lannett Company, Inc.
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2022/09/13
NDC:0527-1242
FLUDARABINE PHOSPHATE
Manufacturer:Accord Healthcare, Inc.
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2022/11/24
NDC:16729-131
Fludarabine Phosphate
Manufacturer:Sagent Pharmaceuticals
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2021/07/22
NDC:25021-242

Singapore Approved Products

FLUDARA FOR INTRAVENOUS INJECTION 50 mg/vial
Manufacturer:INTENDIS MANUFACTURING SPA, BAXTER ONCOLOGY GmbH
Form:INJECTION, POWDER, FOR SOLUTION
Strength:50 mg/vial
Online:Yes
Approved: 1999/10/05
Approval:SIN11143P
FLUDARABINE PHOSPHATE POWDER FOR SOLUTION FOR INJECTION/ INFUSION USP
Manufacturer:Fresenius Kabi Oncology Limited
Form:INJECTION, POWDER, FOR SOLUTION
Strength:50 mg/ vial
Online:Yes
Approved: 2016/06/08
Approval:SIN15030P

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