Gemcitabine Hydrochloride

Treats advanced ovarian cancer. ANDA 79183, held by Hospira Inc. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 79183 (Gemcitabine Hydrochloride), held by Hospira Inc, was first approved by FDA on Nov 15, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 15, 2010
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Gemcitabine 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 6 submissions below

Date	Submission	Status	Documents
Nov 15, 2010	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemcitabine HydrochlorideEQ 2GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Rx

All 6 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 17, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 17, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Nov 15, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 79183
Drugs@FDA: Overview at FDA
Company: Hospira

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