Gemcitabine Hydrochloride

ANDA 202063, held by Emcure Pharms Ltd. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 202063 (Gemcitabine Hydrochloride), held by Emcure Pharms Ltd, was first approved by FDA on Sep 11, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2012
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 11, 2012	Original application	Approved	Review

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 7 submissions, including labeling and manufacturing supplements


Nov 14, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 27, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Nov 27, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 27, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 11, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 202063
Drugs@FDA: Overview at FDA
Company: Emcure 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