Granisetron Hydrochloride

ANDA 78198, held by Baxter Hlthcare Corp. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78198 (Granisetron Hydrochloride), held by Baxter Hlthcare Corp, was first approved by FDA on Jun 30, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 30, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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	Discontinued
Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 26, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jun 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78198
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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