Simvastatin

ANDA 77837, held by Zydus Pharms USA. Simvastatin.

As of Nov 13, 2026, ANDA 77837 (Simvastatin), held by Zydus Pharms USA, was first approved by FDA on Dec 20, 2006, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2006
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 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 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 31, 2022	Supplement 42Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 41Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 40Labeling · Standard review	Approved	None posted
Aug 7, 2019	Supplement 39Labeling · Standard review	Approved	None posted
Aug 7, 2019	Supplement 38Labeling · Standard review	Approved	None posted
Oct 5, 2015	Supplement 35Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 30Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 29Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 27Labeling · Standard review	Approved	None posted
Mar 29, 2012	Supplement 25Labeling	Approved	None posted
Nov 4, 2011	Supplement 24Labeling	Approved	None posted
Jul 25, 2011	Supplement 22Labeling	Approved	None posted
Mar 16, 2011	Supplement 19Labeling	Approved	None posted
Sep 8, 2010	Supplement 18Labeling	Approved	None posted
Nov 18, 2008	Supplement 15Labeling	Approved	None posted
Apr 2, 2008	Supplement 2Labeling	Approved	None posted
Jan 16, 2008	Supplement 9Labeling	Approved	None posted
Dec 20, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77837
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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