Granisol

ANDA 78334, held by Intra Sana Labs. Granisetron Hydrochloride.

As of Nov 15, 2026, ANDA 78334 (Granisol), held by Intra Sana Labs, was first approved by FDA on Feb 28, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 28, 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
Feb 28, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GranisolEQ 2MG BASE/10ML · solution;oral	Granisetron Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Oct 29, 2010	Supplement 2Labeling	Approved	None posted
Oct 29, 2010	Supplement 3Labeling	Approved	None posted
Jun 30, 2008	Supplement 1Labeling	Approved	None posted
Feb 28, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78334
Drugs@FDA: Overview at FDA
Company: Intra Sana Labs

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