ANDA 90663, held by Hameln Rds GmbH. Gemcitabine Hydrochloride.
As of Nov 15, 2026, ANDA 90663 (Gemcitabine Hydrochloride), held by Hameln Rds GmbH, was first approved by FDA on Sep 10, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2012 | 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
