Gemcitabine Hydrochloride

Treats advanced ovarian cancer. ANDA 78339, held by Hospira. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 78339 (Gemcitabine Hydrochloride), held by Hospira, was first approved by FDA on Jul 25, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2011
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Jul 25, 2011	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 8 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Mar 4, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 4, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jun 23, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Jun 23, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Dec 5, 2011	Supplement 1Labeling	Approved	None posted
Jul 25, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 78339
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