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As of Nov 15, 2026, ANDA 208859 (Docetaxel), held by Mylan Labs Ltd, was first approved by FDA on Apr 30, 2018, with 4 approved supplements and 0 published complete response letters.
First approved: Apr 30, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 0
What It's For
From the FDA-approved label (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
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
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal …
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
