Treats advanced ovarian cancer. ANDA 90799, held by Fresenius Kabi USA. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 90799 (Gemcitabine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Jul 25, 2011, with 4 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.
| Jul 25, 2011 | Original application | Approved | None posted |
| May 16, 2011 | 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 |
| Gemcitabine HydrochlorideEQ 2GM BASE/VIAL · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Sep 24, 2024 | Supplement 20Labeling · Standard review | Approved | None posted |
| Oct 6, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 6, 2020 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 18, 2017 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jul 25, 2011 | Original application | Approved | None posted |
| May 16, 2011 | 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
