Gemcitabine Hydrochloride

ANDA 210383, held by Ingenus Pharms LLC. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 210383 (Gemcitabine Hydrochloride), held by Ingenus Pharms LLC, was first approved by FDA on Feb 14, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2019
Review: Standard
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
Feb 14, 2019	Original application	Approved	None posted

Products

3 strengths and forms


Gemcitabine Hydrochloride200MG/5.26ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine Hydrochloride1GM/26.3ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued
Gemcitabine Hydrochloride2GM/52.6ML (38MG/ML) · injectable;injection	Gemcitabine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 9, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jun 15, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 14, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210383
Drugs@FDA: Overview at FDA
Company: Ingenus 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