Gemcitabine Hydrochloride

ANDA 202997, held by Dr Reddys Labs Ltd. Gemcitabine Hydrochloride.

As of Nov 15, 2026, ANDA 202997 (Gemcitabine Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on May 7, 2013, with 1 approved supplement and 0 published complete response letters.

First approved: May 7, 2013
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
May 7, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gemcitabine HydrochlorideEQ 2GM BASE/VIAL · injectable;injection	Gemcitabine Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 2Labeling · Standard review	Approved	None posted
May 7, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202997
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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