Application Nr Approved Date Route Status External Links
ANDA200145 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 Is A Nucleoside Metabolic Inhibitor Indicated: • In Combination With Carboplatin, For The Treatment Of Advanced Ovarian Cancer That Has Relapsed At Least 6 Months After Completion Of Platinum-Based Therapy. ( 1.1 ) • In Combination With Paclitaxel, For First-Line Treatment Of Metastatic Breast Cancer After Failure Of Prior Anthracycline-Containing Adjuvant Chemotherapy, Unless Anthracyclines Were Clinically Contraindicated. ( 1.2 ) • In Combination With Cisplatin, For The Treatment Of Non-Small Cell Lung Cancer. ( 1.3 ) • As A Single Agent For The Treatment Of Pancreatic Cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine 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 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 In Combination With Cisplatin Is Indicated For The First-Line Treatment Of Patients With Inoperable, Locally Advanced (stage Iiia Or Iiib) Or Metastatic (stage Iv) Non-Small Cell Lung Cancer (nsclc). 1.4 Pancreatic Cancer Gemcitabine 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 Fluorouracil.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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