Treats advanced ovarian cancer. ANDA 212129, held by Meitheal. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 212129 (Gemcitabine Hydrochloride), held by Meitheal, was first approved by FDA on Dec 11, 2020, with 1 approved supplement 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 |
|---|---|---|---|
| Dec 11, 2020 | 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 |
| Jul 24, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 11, 2020 | 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
