NDA 209604, held by Accord Hlthcare. Gemcitabine Hydrochloride.
As of Nov 13, 2026, NDA 209604 (Gemcitabine Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Aug 3, 2017, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemcitabine Hydrochloride200MG/2ML (100MG/ML) · solution;intravenous | Gemcitabine Hydrochloride | DiscontinuedReference drug |
| Gemcitabine Hydrochloride1GM/10ML (100MG/ML) · solution;intravenous | Gemcitabine Hydrochloride | DiscontinuedReference drug |
| Gemcitabine Hydrochloride1.5GM/15ML (100MG/ML) · solution;intravenous | Gemcitabine Hydrochloride | DiscontinuedReference drug |
| Gemcitabine Hydrochloride2GM/20ML (100MG/ML) · solution;intravenous | Gemcitabine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Jun 25, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Dec 18, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Jul 30, 2018 | Supplement 3Labeling | Approved | |
| Aug 3, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
