Treats advanced ovarian cancer. ANDA 213175, held by Hikma. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 213175 (Gemcitabine Hydrochloride), held by Hikma, was first approved by FDA on Mar 7, 2023, with 0 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 |
|---|---|---|---|
| Mar 7, 2023 | 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 |
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
