Gemcitabine Hydrochloride

ANDA 204549, held by Actavis Inc. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 204549 (Gemcitabine Hydrochloride), held by Actavis Inc, was first approved by FDA on Apr 11, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 11, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 11, 2016	Original application	Approved	None posted

Products

3 strengths and forms


Gemcitabine Hydrochloride200MG/5.26ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine Hydrochloride1GM/26.3ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine Hydrochloride2GM/52.6ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 17, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jun 23, 2020	Supplement 3Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Apr 11, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204549
Drugs@FDA: Overview at FDA
Company: Actavis

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