Kytril

NDA 21238, held by Roche. Granisetron Hydrochloride.

As of Nov 14, 2026, NDA 21238 (Kytril), held by Roche, was first approved by FDA on Jun 27, 2001, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2001
Review: Standard
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
Jun 27, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
KytrilEQ 2MG BASE/10ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Granisetron Hydrochloride	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Oct 7, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 23, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 25, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 5, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 27, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21238
Drugs@FDA: Overview at FDA
Company: Roche

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