Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). ANDA 207252, held by Hengrui Pharma. Docetaxel.
As of Nov 15, 2026, ANDA 207252 (Docetaxel), held by Hengrui Pharma, was first approved by FDA on Aug 9, 2017, with 6 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 |
|---|---|---|---|
| Aug 9, 2017 | Original application | Approved |
| Sep 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Original application | Approved |
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
