Granisetron Hydrochloride

ANDA 78221, held by Barr. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78221 (Granisetron Hydrochloride), held by Barr, was first approved by FDA on Dec 31, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 31, 2007
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
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 2 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78221
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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