Application Nr Approved Date Route Status External Links
ANDA203738 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Fludarabine Phosphate Injection, Usp Is A Nucleotide Metabolic Inhibitor Indicated 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. Benefit In Treatment-Naïve Or Non-Refractory Cll Patients Is Not Established. ( 1.1 ) 1.1 Indication Fludarabine Phosphate Injection, Usp Is Indicated 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. The Safety And Effectiveness Of Fludarabine Phosphate Injection, Usp In Previously Untreated Or Non-Refractory Patients With Cll Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fludarabine Phosphate FLUDARABINE PHOSPHATE ZINC3927870

Comments