Gemcitabine Hydrochloride

ANDA 207575, held by Adaptis. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 207575 (Gemcitabine Hydrochloride), held by Adaptis, was first approved by FDA on Feb 22, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 22, 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 22, 2019	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Feb 22, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 207575
Drugs@FDA: Overview at FDA
Company: Adaptis

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