Gemcitabine Hydrochloride

Treats advanced ovarian cancer. ANDA 204520, held by Gland. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 204520 (Gemcitabine Hydrochloride), held by Gland, was first approved by FDA on Jan 5, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 5, 2016
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gemcitabine for 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 5 submissions below

Date	Submission	Status	Documents
Jan 5, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jan 5, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204520
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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