Simvastatin

ANDA 76052, held by Ivax Sub Teva Pharms. Simvastatin.

As of Nov 13, 2026, ANDA 76052 (Simvastatin), held by Ivax Sub Teva Pharms, was first approved by FDA on Jun 23, 2006, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2006
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jun 23, 2006	Original application	Approved	Letter

Products

5 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 15, 2025	Supplement 49Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 48Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 44Labeling · Standard review	Approved	None posted
Dec 16, 2015	Supplement 40Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 39Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 38Labeling · Standard review	Approved	None posted
Dec 18, 2012	Supplement 37Labeling · Standard review	Approved	None posted
Mar 23, 2012	Supplement 34Labeling	Approved	None posted
Nov 22, 2011	Supplement 32Labeling	Approved	None posted
Jul 26, 2011	Supplement 31Labeling	Approved	None posted
Feb 16, 2011	Supplement 29Labeling	Approved	None posted
Sep 17, 2010	Supplement 26Labeling	Approved	None posted
May 17, 2010	Supplement 23Labeling	Approved	None posted
Apr 12, 2010	Supplement 21Labeling	Approved	None posted
Sep 24, 2009	Supplement 17Labeling	Approved	None posted
Aug 18, 2009	Supplement 14Labeling	Approved	None posted
Apr 25, 2008	Supplement 11Labeling	Approved	None posted
Dec 20, 2006	Supplement 5Labeling	Approved	None posted
Dec 20, 2006	Supplement 4Manufacturing	Approved	None posted
Jun 23, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 76052
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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