Treats advanced ovarian cancer. ANDA 202485, held by Jiangsu Hansoh Pharm. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 202485 (Gemcitabine Hydrochloride), held by Jiangsu Hansoh Pharm, was first approved by FDA on May 7, 2013, with 5 approved supplements and 0 published complete response letters.
Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. in combination with cisplatin, for the treatment of non-small cell lung cancer. as a single agent for the treatment of pancreatic cancer. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2013 | Original application | Approved | None posted |
| Gemcitabine HydrochlorideEQ 200MG BASE/VIAL · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Gemcitabine HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Sep 24, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 7, 2013 | 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
