Simvastatin

Lowers the risk of total mortality. ANDA 78155, held by Accord Hlthcare. Simvastatin.

As of Nov 14, 2026, ANDA 78155 (Simvastatin), held by Accord Hlthcare, was first approved by FDA on Feb 26, 2008, with 20 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2008
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Feb 26, 2008	Original application	Approved	None posted

Products

5 strengths and forms


Simvastatin80MG · tablet;oral	Simvastatin	Rx
Simvastatin10MG · tablet;oral	Simvastatin	Rx
Simvastatin20MG · tablet;oral	Simvastatin	Rx
Simvastatin40MG · tablet;oral	Simvastatin	Rx
Simvastatin5MG · tablet;oral	Simvastatin	Rx

All 21 submissions, including labeling and manufacturing supplements


Mar 3, 2025	Supplement 41Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 39Labeling · Standard review	Approved	None posted
Oct 13, 2022	Supplement 38Labeling · Standard review	Approved	None posted
Oct 13, 2022	Supplement 36Labeling · Standard review	Approved	None posted
Jun 23, 2020	Supplement 35Labeling · Standard review	Approved	None posted
Aug 22, 2019	Supplement 32Labeling · Standard review	Approved	None posted
Dec 31, 2018	Supplement 30Labeling · Standard review	Approved	None posted
Oct 20, 2015	Supplement 21Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 20Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Sep 30, 2013	Supplement 10Manufacturing	Approved	None posted
Jan 27, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Sep 28, 2012	Supplement 15Labeling · Standard review	Approved	None posted
Sep 27, 2012	Supplement 16Manufacturing	Approved	None posted
Jan 11, 2012	Supplement 14Labeling	Approved	None posted
Jan 11, 2012	Supplement 13Labeling	Approved	None posted
Nov 4, 2011	Supplement 12Labeling	Approved	None posted
Feb 22, 2011	Supplement 9Labeling	Approved	None posted
Sep 20, 2010	Supplement 7Labeling	Approved	None posted
Nov 25, 2008	Supplement 1Labeling	Approved	None posted
Feb 26, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78155
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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