Granisetron Hydrochloride

ANDA 77842, held by Hikma. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 77842 (Granisetron Hydrochloride), held by Hikma, was first approved by FDA on Dec 31, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 31, 2007	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Aug 12, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Nov 4, 2014	Supplement 3Manufacturing	Approved	None posted
Sep 18, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Jun 7, 2010	Supplement 6Labeling	Approved	None posted
Nov 24, 2008	Supplement 1Labeling	Approved	None posted
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77842
Drugs@FDA: Overview at FDA
Company: Hikma

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