Gemcitabine Hydrochloride

ANDA 206776, held by Apotex. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 206776 (Gemcitabine Hydrochloride), held by Apotex, was first approved by FDA on May 23, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: May 23, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 23, 2017	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 5 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Aug 4, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 22, 2019	Supplement 3Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 2Labeling · Standard review	Approved	None posted
May 23, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206776
Drugs@FDA: Overview at FDA
Company: Apotex

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