Treats advanced ovarian cancer. ANDA 91365, held by Dr Reddys Labs Ltd. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 91365 (Gemcitabine Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Jul 25, 2011, with 6 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 |
|---|---|---|---|
| Jul 25, 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 |
| Sep 24, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 1, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 26, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 26, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 26, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 25, 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
