Cytovene

NDA 19661, held by Cheplapharm. Ganciclovir Sodium.

As of Nov 14, 2026, NDA 19661 (Cytovene), held by Cheplapharm, was first approved by FDA on Jun 23, 1989, with 32 approved supplements and 0 published complete response letters.

First approved: Jun 23, 1989
Review: Priority
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below


Aug 6, 2018	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Label
May 15, 1992	Supplement 8Efficacy (new indication or use)	Approved	None posted
Jun 23, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
CytoveneEQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ganciclovir Sodium	DiscontinuedReference drug

All 33 submissions, including labeling and manufacturing supplements


May 20, 2020	Supplement 38Labeling · Standard review	Approved	Label Letter
Aug 6, 2018	Supplement 37Efficacy (new indication or use) · Standard review	Approved	Label
Jul 3, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 17, 2016	Supplement 35Manufacturing	Approved	None posted
Apr 8, 2013	Supplement 34Manufacturing	Approved	None posted
Jan 31, 2006	Supplement 30Labeling · Standard review	Approved	Label Letter
Oct 25, 2002	Supplement 29Manufacturing	Approved	None posted
Sep 23, 2002	Supplement 28Manufacturing	Approved	None posted
Mar 21, 2002	Supplement 27Manufacturing	Approved	None posted
Dec 1, 2000	Supplement 24Labeling · Standard review	Approved	None posted
May 11, 2000	Supplement 26Manufacturing	Approved	None posted
Mar 30, 2000	Supplement 25Manufacturing	Approved	None posted
Aug 27, 1999	Supplement 23Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 22Labeling · Standard review	Approved	None posted
May 23, 1997	Supplement 21Manufacturing	Approved	None posted
Aug 8, 1996	Supplement 18Manufacturing	Approved	None posted
May 29, 1996	Supplement 20Labeling · Standard review	Approved	None posted
May 8, 1996	Supplement 19Labeling · Standard review	Approved	None posted
Jul 20, 1995	Supplement 17Manufacturing	Approved	None posted
Apr 28, 1995	Supplement 16Manufacturing	Approved	None posted
Jan 20, 1995	Supplement 15Labeling · Standard review	Approved	None posted
Sep 30, 1994	Supplement 13Manufacturing	Approved	None posted
Sep 13, 1994	Supplement 14Manufacturing	Approved	None posted
Feb 9, 1993	Supplement 3Manufacturing	Approved	None posted
Jan 15, 1993	Supplement 10Manufacturing	Approved	None posted
Oct 9, 1992	Supplement 11Manufacturing	Approved	None posted
Sep 30, 1992	Supplement 12Manufacturing	Approved	None posted
Jul 17, 1992	Supplement 6Manufacturing	Approved	None posted
Jun 19, 1992	Supplement 7Manufacturing	Approved	None posted
May 15, 1992	Supplement 8Efficacy (new indication or use)	Approved	None posted
Jul 24, 1990	Supplement 4Labeling	Approved	None posted
Jan 11, 1990	Supplement 2Labeling	Approved	None posted
Jun 23, 1989	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19661
Drugs@FDA: Overview at FDA
Company: Cheplapharm

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