Granisetron Hydrochloride

ANDA 78080, held by Teva Pharms. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78080 (Granisetron Hydrochloride), held by Teva Pharms, was first approved by FDA on Dec 31, 2007, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2007
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 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 5 submissions, including labeling and manufacturing supplements


Aug 12, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Apr 11, 2012	Supplement 4Labeling	Approved	Label
Jan 28, 2010	Supplement 1Labeling	Approved	None posted
Dec 31, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78080
Drugs@FDA: Overview at FDA
Company: Teva 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