Treats advanced ovarian cancer. ANDA 209077, held by Sagent Pharms Inc. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 209077 (Gemcitabine Hydrochloride), held by Sagent Pharms Inc, was first approved by FDA on Jul 20, 2018, with 2 approved supplements and 0 published complete response letters.
Gemcitabine 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 20, 2018 | Original application | Approved | None posted |
| Gemcitabine Hydrochloride200MG/5.26ML (38MG/ML) · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Gemcitabine Hydrochloride1GM/26.3ML (38MG/ML) · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Gemcitabine Hydrochloride2GM/52.6ML (38MG/ML) · injectable;injection | Gemcitabine Hydrochloride | Rx |
| Mar 13, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 4, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 20, 2018 | 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
