Granisetron Hydrochloride

ANDA 78090, held by Fresenius Kabi USA. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78090 (Granisetron Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Jun 30, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2008
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 30, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


May 19, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 15, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Jun 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78090
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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