Simvastatin

Lowers the risk of total mortality. Sold as Zocor, Simvastatin, Flolipid. Every FDA application for this active ingredient: 3 branded and 17 generic.

As of Nov 13, 2026, FDA lists 20 applications for Simvastatin (sold as Zocor, Simvastatin, Flolipid), first approved Dec 23, 1991, with 13 new uses approved and 0 published complete response letters.

First approved: Dec 23, 1991
Applications: 20
New uses approved: 13
Complete response letters: 0
Medicare spending, 2025: $123M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Simvastatin	Part D	$121M	-4%	3,389,173
Zocor	Part D	$1.4M	-11%	581
Flolipid	Part D	$0K	-100%	0

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Dec 23, 1991	ZocorNDA 19766 · New molecular entity	Organon	86	Marketed
Jun 23, 2006	SimvastatinANDA 76052	Ivax Sub Teva Pharms	19	Discontinued
Jun 23, 2006	SimvastatinANDA 76285	Sun Pharm Inds Ltd	5	Discontinued
Dec 20, 2006	SimvastatinANDA 76685	Watson Labs Teva	4	Discontinued
Dec 20, 2006	SimvastatinANDA 77691	Aurobindo Pharma	21	Marketed
Dec 20, 2006	SimvastatinANDA 77752	Rising	12	Marketed
Dec 20, 2006	SimvastatinANDA 77766	Chartwell Rx	4	Discontinued
Dec 20, 2006	SimvastatinANDA 77837	Zydus Pharms USA	17	Marketed
Dec 20, 2006	SimvastatinANDA 78034	Biocon Pharma	11	Marketed
May 11, 2007	SimvastatinANDA 78103	Lupin	15	Marketed
Oct 9, 2007	SimvastatinNDA 21961 · New dosage form	Synthon Pharms	0	Discontinued
Feb 26, 2008	SimvastatinANDA 78155	Accord Hlthcare	20	Marketed
Jun 8, 2010	SimvastatinANDA 90868	Pharmobedient	4	Discontinued
Aug 30, 2010	SimvastatinANDA 78735	Tp Anda Holdings	0	Marketed
Sep 16, 2011	SimvastatinANDA 90383	Micro Labs	12	Discontinued
Nov 25, 2014	SimvastatinANDA 200895	Hetero Labs Ltd Iii	6	Marketed
Apr 21, 2016	FlolipidNDA 206679 · New dosage form	Salerno Pharms	2	Marketed
Nov 13, 2017	SimvastatinANDA 206557	Invagen Pharms	6	Marketed
Nov 27, 2024	SimvastatinANDA 211394	Pharmobedient	0	Marketed
—	SimvastatinANDA 76532	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. Drugs@FDA