Simvastatin

Lowers the risk of total mortality. ANDA 78034, held by Biocon Pharma. Simvastatin.

As of Nov 13, 2026, ANDA 78034 (Simvastatin), held by Biocon Pharma, was first approved by FDA on Dec 20, 2006, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2006
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (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 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 12 submissions below

Date	Submission	Status	Documents
Dec 20, 2006	Original application	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Simvastatin5MG · tablet;oral	Simvastatin	Rx
Simvastatin10MG · tablet;oral	Simvastatin	Rx
Simvastatin20MG · tablet;oral	Simvastatin	Rx
Simvastatin40MG · tablet;oral	Simvastatin	Rx
Simvastatin80MG · tablet;oral	Simvastatin	Rx

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 16, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 16Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 17Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Mar 6, 2019	Supplement 12Labeling · Standard review	Approved	None posted
May 5, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Oct 8, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Mar 25, 2013	Supplement 6Labeling	Approved	None posted
Dec 20, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 78034
Drugs@FDA: Overview at FDA
Company: Biocon Pharma

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