ANDA 202031, held by Am Regent. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 202031 (Gemcitabine Hydrochloride), held by Am Regent, was first approved by FDA on May 7, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2013 | Original application | Approved | None posted |
| Gemcitabine HydrochlorideEQ 200MG BASE/VIAL · injectable;injection | Gemcitabine Hydrochloride | Discontinued |
| Gemcitabine HydrochlorideEQ 1GM BASE/VIAL · injectable;injection | Gemcitabine Hydrochloride | Discontinued |
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
