Application Nr Approved Date Route Status External Links
ANDA090242 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Gemcitabine For Injection, Usp Is A Nucleoside Metabolic Inhibitor Indicated For: Ovarian Cancer In Combination With Carboplatin ( 1.1 ) Breast Cancer In Combination With Paclitaxel ( 1.2 ) Non-Small Cell Lung Cancer In Combination With Cisplatin ( 1.3 ) Pancreatic Cancer As A Single-Agent ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine For Injection In Combination With Carboplatin Is Indicated For The Treatment Of Patients With Advanced Ovarian Cancer That Has Relapsed At Least 6 Months After Completion Of Platinum-Based Therapy. 1.2 Breast Cancer Gemcitabine For Injection In Combination With Paclitaxel Is Indicated For The First-Line Treatment Of Patients With Metastatic Breast Cancer After Failure Of Prior Anthracycline-Containing Adjuvant Chemotherapy, Unless Anthracyclines Were Clinically Contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine For Injection Is Indicated In Combination With Cisplatin For The First-Line Treatment Of Patients With Inoperable, Locally Advanced (stage Iiia Or Iiib), Or Metastatic (stage Iv) Non-Small Cell Lung Cancer. 1.4 Pancreatic Cancer Gemcitabine For Injection Is Indicated As First-Line Treatment For Patients With Locally Advanced (nonresectable Stage Ii Or Stage Iii) Or Metastatic (stage Iv) Adenocarcinoma Of The Pancreas. Gemcitabine Is Indicated For Patients Previously Treated With 5-Fu.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Gemcitabine Hydrochloride GEMCITABINE HYDROCHLORIDE ZINC18279854

Comments