Application Nr Approved Date Route Status External Links
ANDA210327 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Docetaxel Injection Is A Microtubule Inhibitor Indicated For: Breast Cancer (bc) : Single Agent For Locally Advanced Or Metastatic Bc After Chemotherapy Failure; And With Doxorubicin And Cyclophosphamide As Adjuvant Treatment Of Operable Node-Positive Bc ( 1.1 ) Non-Small Cell Lung Cancer (nsclc) : Single Agent For Locally Advanced Or Metastatic Nsclc After Platinum Therapy Failure; And With Cisplatin For Unresectable, Locally Advanced Or Metastatic Untreated Nsclc ( 1.2 ) Castration-Resistant Prostate Cancer (crpc) : With Prednisone In Metastatic Castration-Resistant Prostate Cancer ( 1.3 ) Gastric Adenocarcinoma (gc) : With Cisplatin And Fluorouracil For Untreated, Advanced Gc, Including The Gastroesophageal Junction ( 1.4 ) Squamous Cell Carcinoma Of The Head And Neck (scchn) : With Cisplatin And Fluorouracil For Induction Treatment Of Locally Advanced Scchn ( 1.5 ) 1.1 Breast Cancer Docetaxel Injection Is Indicated For The Treatment Of Patients With Locally Advanced Or Metastatic Breast Cancer After Failure Of Prior Chemotherapy. Docetaxel Injection In Combination With Doxorubicin And Cyclophosphamide Is Indicated For The Adjuvant Treatment Of Patients With Operable Node-Positive Breast Cancer. 1.2 Non-Small Cell Lung Cancer Docetaxel Injection As A Single Agent Is Indicated For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of Prior Platinum-Based Chemotherapy. Docetaxel Injection In Combination With Cisplatin Is Indicated For The Treatment Of Patients With Unresectable, Locally Advanced Or Metastatic Non-Small Cell Lung Cancer Who Have Not Previously Received Chemotherapy For This Condition. 1.3 Prostate Cancer Docetaxel Injection In Combination With Prednisone Is Indicated For The Treatment Of Patients With Metastatic Castration-Resistant Prostate Cancer. 1.4 Gastric Adenocarcinoma Docetaxel Injection In Combination With Cisplatin And Fluorouracil Is Indicated For The Treatment Of Patients With Advanced Gastric Adenocarcinoma, Including Adenocarcinoma Of The Gastroesophageal Junction, Who Have Not Received Prior Chemotherapy For Advanced Disease. 1.5 Head And Neck Cancer Docetaxel Injection In Combination With Cisplatin And Fluorouracil Is Indicated For The Induction Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (scchn).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Docetaxel DOCETAXEL ZINC85537053

Comments