Granisetron Hydrochloride

ANDA 78392, held by Dr Reddys. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78392 (Granisetron Hydrochloride), held by Dr Reddys, was first approved by FDA on Dec 31, 2007, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2007
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 31, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Granisetron HydrochlorideEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
May 30, 2013	Supplement 13Labeling · Standard review	Approved	None posted
May 30, 2013	Supplement 14Labeling · Standard review	Approved	None posted
Apr 13, 2012	Supplement 11Labeling	Approved	Label
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78392
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