Gemcitabine Hydrochloride

ANDA 91594, held by Accord Hlthcare. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 91594 (Gemcitabine Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Jul 25, 2011, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2011
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 25, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Gemcitabine HydrochlorideEQ 200MG BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine HydrochlorideEQ 1GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine HydrochlorideEQ 2GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Sep 24, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Oct 17, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Oct 17, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Oct 17, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Jun 2, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Sep 6, 2011	Supplement 1Labeling	Approved	None posted
Jul 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91594
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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