Granisetron Hydrochloride

ANDA 78725, held by Aurobindo Pharma USA. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78725 (Granisetron Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Jan 30, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 30, 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
Jan 30, 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 5Labeling · Standard review	Approved	None posted
Sep 17, 2010	Supplement 2Labeling	Approved	None posted
Jan 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78725
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma 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