Application Nr Approved Date Route Status External Links
ANDA207326 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Paclitaxel Injection, Usp Is Indicated As Subsequent Therapy For The Treatment Of Advanced Carcinoma Of The Ovary. As First-Line Therapy, Paclitaxel Is Indicated In Combination With Cisplatin. Paclitaxel Is Indicated For The Adjuvant Treatment Of Node-Positive Breast Cancer Administered Sequentially To Standard Doxorubicin-Containing Combination Chemotherapy. In The Clinical Trial, There Was An Overall Favorable Effect On Disease-Free And Overall Survival In The Total Population Of Patients With Receptor-Positive And Receptor-Negative Tumors, But The Benefit Has Been Specifically Demonstrated By Available Data (median Follow-Up 30 Months) Only In The Patients With Estrogen And Progesterone Receptornegative Tumors (see Clinical Studies, Breast Carcinoma ). Paclitaxel Injection, Usp Is Indicated For The Treatment Of Breast Cancer After Failure Of Combination Chemotherapy For Metastatic Disease Or Relapse Within 6 Months Of Adjuvant Chemotherapy. Prior Therapy Should Have Included An Anthracycline Unless Clinically Contraindicated. Paclitaxel, In Combination With Cisplatin, Is Indicated For The First-Line Treatment Of Nonsmall Cell Lung Cancer In Patients Who Are Not Candidates For Potentially Curative Surgery And/or Radiation Therapy. Paclitaxel Is Indicated For The Second-Line Treatment Of Aids-Related Kaposi's Sarcoma.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paclitaxel PACLITAXEL ZINC96006020

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