Granisetron Hydrochloride

ANDA 78534, held by Sandoz. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78534 (Granisetron Hydrochloride), held by Sandoz, was first approved by FDA on Apr 30, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2009
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 30, 2009	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 3 submissions, including labeling and manufacturing supplements


Apr 28, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Apr 30, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78534
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