Granisetron Hydrochloride

ANDA 90817, held by Taro. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 90817 (Granisetron Hydrochloride), held by Taro, was first approved by FDA on May 28, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: May 28, 2010
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
May 28, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 2Labeling · Standard review	Approved	None posted
May 28, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90817
Drugs@FDA: Overview at FDA
Company: Taro 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