Gemcitabine Hydrochloride

Treats advanced ovarian cancer. ANDA 205242, held by Mylan Labs Ltd. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 205242 (Gemcitabine Hydrochloride), held by Mylan Labs Ltd, was first approved by FDA on Dec 6, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:

in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
in combination with cisplatin for the treatment of non-small cell lung cancer.
as a single agent for the treatment of pancreatic cancer. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 6, 2017	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Aug 4, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Feb 28, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 3, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 6, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 205242
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

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