Granisetron Hydrochloride

ANDA 78808, held by Sandoz. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78808 (Granisetron Hydrochloride), held by Sandoz, was first approved by FDA on Apr 29, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 29, 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
Apr 29, 2008	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	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 13, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Sep 3, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Apr 17, 2012	Supplement 6Labeling	Approved	None posted
Apr 29, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78808
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