Granisetron Hydrochloride

ANDA 78846, held by Dr Reddys Labs Ltd. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78846 (Granisetron Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Feb 27, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2009
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
Feb 27, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Jul 20, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 20, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Sep 23, 2010	Supplement 1Labeling	Approved	None posted
Feb 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78846
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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