Gemcitabine Hydrochloride

ANDA 90242, held by Fresenius Kabi USA. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 90242 (Gemcitabine Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on May 17, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: May 17, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 17, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Gemcitabine HydrochlorideEQ 200MG BASE/VIAL · injectable; injection	Gemcitabine Hydrochloride	None (tentative approval)
Gemcitabine HydrochlorideEQ 1GM BASE/VIAL · injectable; injection	Gemcitabine Hydrochloride	None (tentative approval)
Gemcitabine HydrochlorideEQ 2GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Sep 12, 2024	Supplement 4Labeling · Standard review	Approved	None posted
May 17, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90242
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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