Kytril

NDA 20239, held by Roche. Granisetron Hydrochloride.

As of Nov 13, 2026, NDA 20239 (Kytril), held by Roche, was first approved by FDA on Dec 29, 1993, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1993
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Apr 29, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 16, 2002	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 21, 1997	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 29, 1993	Original applicationNew molecular entity · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review

Products

4 strengths and forms

Product	Active ingredient	Marketing
KytrilEQ 3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Granisetron Hydrochloride	DiscontinuedReference drug
KytrilEQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Granisetron Hydrochloride	DiscontinuedReference drug
KytrilEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Granisetron Hydrochloride	DiscontinuedReference drug
KytrilEQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Granisetron Hydrochloride	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 29, 2011	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
Nov 23, 2005	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Sep 17, 2004	Supplement 17Manufacturing · Standard review	Approved	Review Letter
Sep 17, 2004	Supplement 16Manufacturing · Standard review	Approved	Review Letter
Aug 20, 2004	Supplement 15Manufacturing · Standard review	Approved	Review Letter Label
Nov 25, 2002	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 5, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 16, 2002	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 30, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 20, 1997	Supplement 7Labeling · Standard review	Approved	Review
Jan 21, 1997	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 21, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Oct 24, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 21, 1995	Supplement 3Labeling · Standard review	Approved	None posted
Mar 11, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 29, 1993	Original applicationNew molecular entity · Standard review	Approved	Pediatric Medical Review Pediatric Clinical Pharmacology Review Pediatric Statistical Review

Identifiers

Application: NDA 20239
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