Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). ANDA 213768, held by Guangdong Sunho. Docetaxel.
As of Nov 15, 2026, ANDA 213768 (Docetaxel), held by Guangdong Sunho, was first approved by FDA on May 13, 2025, with 0 approved supplements and 0 published complete response letters.
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 junction…
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2025 | Original application | Approved | None posted |
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
