Gemcitabine Hydrochloride

ANDA 206617, held by Hikma Intl Pharms. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 206617 (Gemcitabine Hydrochloride), held by Hikma Intl Pharms, was first approved by FDA on Jun 25, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 25, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 25, 2021	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jun 25, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 206617
Drugs@FDA: Overview at FDA
Company: Hikma International 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