Granisetron Hydrochloride

ANDA 79078, held by Rising. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 79078 (Granisetron Hydrochloride), held by Rising, was first approved by FDA on Sep 14, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 14, 2009
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 14, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Granisetron HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx
Granisetron HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · injectable;injection	Granisetron Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 1, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Mar 31, 2011	Supplement 1Labeling	Approved	None posted
Sep 14, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79078
Drugs@FDA: Overview at FDA
Company: Rising 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