Granisetron Hydrochloride

ANDA 78843, held by Apotex Inc. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78843 (Granisetron Hydrochloride), held by Apotex Inc, was first approved by FDA on Feb 27, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2008
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
Feb 27, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Aug 25, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Feb 27, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78843
Drugs@FDA: Overview at FDA
Company: Apotex

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