Granisetron Hydrochloride

ANDA 78678, held by Orbion Pharms. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78678 (Granisetron Hydrochloride), held by Orbion Pharms, was first approved by FDA on Feb 13, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 13, 2008
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Granisetron hydrochloride tablets are indicated for the prevention of: Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 13, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Granisetron HydrochlorideEQ 1MG BASE · tablet;oral	Granisetron Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 12, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Sep 15, 2010	Supplement 2Labeling	Approved	None posted
Feb 13, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78678
Drugs@FDA: Overview at FDA
Company: Orbion Pharmaceuticals

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