Granisetron Hydrochloride

ANDA 78969, held by Natco Pharma. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78969 (Granisetron Hydrochloride), held by Natco Pharma, was first approved by FDA on Jun 22, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2009
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Granisetron hydrochloride tablets USP 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 6 submissions below

Date	Submission	Status	Documents
Jun 22, 2009	Original application	Approved	Other

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Aug 22, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Oct 17, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Dec 7, 2011	Supplement 1Labeling	Approved	None posted
Jun 22, 2009	Original application	Approved	Other

Identifiers

Application: ANDA 78969
Drugs@FDA: Overview at FDA
Company: Natco Pharma

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