Ribavirin

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Dec 31, 1985	VirazoleNDA 18859 · New molecular entity	Bausch	20	Discontinued
Jun 3, 1998	RebetolNDA 20903 · New dosage form	Merck Sharp Dohme	46	Discontinued
Dec 3, 2002	CopegusNDA 21511 · New dosage form	Roche	20	Discontinued
Jul 29, 2003	RebetolNDA 21546 · New dosage form	Schering	11	Discontinued
Apr 6, 2004	RibavirinANDA 76192	Chartwell Rx	9	Discontinued
Apr 6, 2004	RibasphereANDA 76203	Chartwell Rx	8	Discontinued
Oct 4, 2004	RibavirinANDA 76277	Teva	11	Discontinued
Oct 28, 2005	RibavirinANDA 77224	Zydus Pharms USA	14	Marketed
Dec 5, 2005	RibavirinANDA 77053	Heritage Pharma Avet	12	Discontinued
Dec 5, 2005	RibavirinANDA 77094	Zydus Pharms USA	15	Marketed
Dec 5, 2005	RibavirinANDA 77456	Chartwell Rx	10	Discontinued
Oct 3, 2006	RibavirinANDA 77743	Sandoz	6	Marketed
Sep 17, 2009	RibavirinANDA 79111	Aurobindo Pharma	5	Marketed
Sep 17, 2009	RibavirinANDA 79117	Aurobindo Pharma	10	Marketed
Aug 12, 2014	RibavirinANDA 202546	Beximco Pharms USA	0	Discontinued
Oct 6, 2016	RibavirinANDA 207366	Chartwell Rx	0	Discontinued
—	RibavirinANDA 77611	Teva Pharms	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