Granisetron Hydrochloride

ANDA 78835, held by Sandoz Inc. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78835 (Granisetron Hydrochloride), held by Sandoz Inc, was first approved by FDA on Jun 30, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2008
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
Jun 30, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx
Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Jul 15, 2015	Supplement 13Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Apr 17, 2012	Supplement 8Labeling	Approved	None posted
Jan 28, 2010	Supplement 6Labeling	Approved	None posted
Jun 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78835
Drugs@FDA: Overview at FDA
Company: Sandoz

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