Gemcitabine Hydrochloride

ANDA 79160, held by Actavis Totowa. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 79160 (Gemcitabine Hydrochloride), held by Actavis Totowa, 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 13Labeling · Standard review	Approved	None posted
Feb 28, 2020	Supplement 11Labeling · Standard review	Approved	None posted
May 1, 2019	Supplement 10Labeling · Standard review	Approved	None posted
May 1, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Jul 28, 2016	Supplement 3Manufacturing	Approved	None posted
May 7, 2015	Supplement 2Manufacturing	Approved	None posted
Apr 2, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jul 8, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jul 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 79160
Drugs@FDA: Overview at FDA
Company: Actavis Totowa

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