Granisetron Hydrochloride

ANDA 77963, held by Teva Pharms USA. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 77963 (Granisetron Hydrochloride), held by Teva Pharms USA, was first approved by FDA on Jan 3, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 3, 2008
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
Jan 3, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
May 30, 2013	Supplement 12Labeling · Standard review	Approved	None posted
May 30, 2013	Supplement 13Labeling · Standard review	Approved	None posted
Apr 11, 2012	Supplement 10Labeling	Approved	Label
Jan 3, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77963
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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