Simvastatin

ANDA 77691, held by Aurobindo Pharma. Simvastatin.

As of Nov 13, 2026, ANDA 77691 (Simvastatin), held by Aurobindo Pharma, was first approved by FDA on Dec 20, 2006, with 21 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2006
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 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 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 31, 2024	Supplement 48Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 47Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 43Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 44Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 45Labeling · Standard review	Approved	None posted
May 5, 2020	Supplement 40Labeling · Standard review	Approved	None posted
Aug 7, 2019	Supplement 38Labeling · Standard review	Approved	None posted
Dec 31, 2018	Supplement 36Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 33Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 26Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 28Labeling · Standard review	Approved	None posted
Nov 28, 2012	Supplement 19Labeling · Standard review	Approved	None posted
Apr 26, 2012	Supplement 18Labeling	Approved	None posted
Mar 2, 2012	Supplement 10Manufacturing	Approved	None posted
Jan 11, 2012	Supplement 16Labeling	Approved	None posted
Jul 26, 2011	Supplement 15Labeling	Approved	None posted
May 8, 2011	Supplement 14Labeling	Approved	None posted
Sep 18, 2010	Supplement 12Manufacturing	Approved	None posted
Sep 8, 2010	Supplement 11Labeling	Approved	None posted
Apr 3, 2009	Supplement 5Labeling	Approved	None posted
Jun 9, 2008	Supplement 3Labeling	Approved	None posted
Dec 20, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77691
Drugs@FDA: Overview at FDA
Company: Aurobindo 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