Gemcitabine Hydrochloride

Treats advanced ovarian cancer. NDA 200795, held by Hospira Inc. Gemcitabine Hydrochloride.

As of Nov 13, 2026, NDA 200795 (Gemcitabine Hydrochloride), held by Hospira Inc, was first approved by FDA on Aug 4, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 4, 2011
Review: Standard
Supplements approved: 9
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 10 submissions below

Date	Submission	Status	Documents
Aug 4, 2011	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Gemcitabine Hydrochloride200MG/5.26ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	RxReference drug
Gemcitabine Hydrochloride1GM/26.3ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	RxReference drug
Gemcitabine Hydrochloride2GM/52.6ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 31, 2024	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 21, 2019	Supplement 10Labeling · Standard review	Approved	Label Letter
Jan 26, 2018	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 7, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
May 8, 2014	Supplement 5Labeling	Approved	Label Letter
Nov 27, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 5, 2013	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 20, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 18, 2012	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 4, 2011	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 200795
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