Ezetimibe And Simvastatin

Lowers the risk of total mortality. ANDA 209222, held by Alkem Labs Ltd. Ezetimibe; Simvastatin.

As of Nov 15, 2026, ANDA 209222 (Ezetimibe And Simvastatin), held by Alkem Labs Ltd, was first approved by FDA on Dec 22, 2017, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2017
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ezetimibe and Simvastatin Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated:

As an adjunct to diet to reduce elevated 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).
As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).

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
Dec 22, 2017	Original application	Approved	None posted

Products

4 strengths and forms


Ezetimibe And Simvastatin10MG;10MG · tablet;oral	Ezetimibe; Simvastatin	Rx
Ezetimibe And Simvastatin10MG;20MG · tablet;oral	Ezetimibe; Simvastatin	Rx
Ezetimibe And Simvastatin10MG;40MG · tablet;oral	Ezetimibe; Simvastatin	Rx
Ezetimibe And Simvastatin10MG;80MG · tablet;oral	Ezetimibe; Simvastatin	Rx

All 7 submissions, including labeling and manufacturing supplements


Jul 15, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 16, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Feb 23, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Sep 26, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Dec 22, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 209222
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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