Granisetron Hydrochloride

ANDA 78522, held by Fresenius Kabi USA. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78522 (Granisetron Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Dec 31, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2007
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
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 4 submissions, including labeling and manufacturing supplements


May 18, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 14, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78522
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