Granisetron Hydrochloride

ANDA 78197, held by Baxter Hlthcare Corp. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78197 (Granisetron Hydrochloride), held by Baxter Hlthcare Corp, was first approved by FDA on Dec 31, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2007
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
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	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 21, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78197
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