Gemcitabine Hydrochloride

ANDA 210991, held by Adaptis. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 210991 (Gemcitabine Hydrochloride), held by Adaptis, was first approved by FDA on Oct 4, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 4, 2019
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
Oct 4, 2019	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 4, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Oct 4, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210991
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