Simvastatin

Lowers the risk of total mortality. ANDA 200895, held by Hetero Labs Ltd Iii. Simvastatin.

As of Nov 13, 2026, ANDA 200895 (Simvastatin), held by Hetero Labs Ltd Iii, was first approved by FDA on Nov 25, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 25, 2014
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Simvastatin tablets are indicated:

To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 25, 2014	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 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 31, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Aug 31, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Nov 5, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 25, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 200895
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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