Granisetron Hydrochloride

Prevents nausea and/or vomiting associated with initial and repeat courses of emetogenic…. ANDA 91137, held by Mylan Asi. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 91137 (Granisetron Hydrochloride), held by Mylan Asi, was first approved by FDA on Apr 9, 2010, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 9, 2010
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Granisetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for:

The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 9, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Granisetron Hydrochloride1MG/ML · injectable; injection	Granisetron Hydrochloride	Rx
Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Nov 8, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 15, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Aug 6, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Aug 6, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Apr 18, 2012	Supplement 2Labeling	Approved	None posted
Apr 1, 2011	Supplement 1Labeling	Approved	None posted
Apr 9, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91137
Drugs@FDA: Overview at FDA
Company: Mylan ASI

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