Ganciclovir Sodium

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jun 23, 1989	CytoveneNDA 19661 · New molecular entity	Cheplapharm	32	Discontinued
Jul 16, 2003	Ganciclovir SodiumANDA 76222	Hikma	3	Marketed
Jun 21, 2010	Ganciclovir SodiumANDA 90658	Fresenius Kabi USA	2	Marketed
Sep 18, 2013	Ganciclovir SodiumANDA 202624	Am Regent	2	Discontinued
Dec 6, 2016	Ganciclovir SodiumANDA 204950	Ph Health	1	Marketed
Nov 17, 2017	Ganciclovir SodiumANDA 204560	Onesource Specialty	1	Discontinued
Dec 8, 2017	Ganciclovir SodiumANDA 207645	Pharmascience Inc	2	Marketed
Nov 8, 2018	Ganciclovir SodiumANDA 204204	Hainan Poly	0	Marketed
Jun 20, 2019	Ganciclovir SodiumANDA 212001	Custopharm Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA