Gemcitabine Hydrochloride

ANDA 77983, held by Teva Pharms. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 77983 (Gemcitabine Hydrochloride), held by Teva Pharms, was first approved by FDA on Jan 25, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 25, 2011
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 25, 2011	Original application	Approved	Letter Letter

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


May 18, 2015	Supplement 3Labeling	Approved	None posted
May 18, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Sep 6, 2011	Supplement 9Labeling	Approved	None posted
Aug 30, 2011	Supplement 8Labeling	Approved	None posted
Jan 25, 2011	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 77983
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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