Simvastatin

As of Nov 13, 2026, ANDA 78103 (Simvastatin), held by Lupin, was first approved by FDA on May 11, 2007, with 15 approved supplements and 0 published complete response letters.

First approved: May 11, 2007
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
May 11, 2007	Original application	Approved	None posted

Products

5 strengths and forms

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

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 31, 2024	Supplement 54Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 50Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 49Labeling · Standard review	Approved	None posted
Aug 29, 2022	Supplement 46Labeling · Standard review	Approved	None posted
May 28, 2020	Supplement 44Labeling · Standard review	Approved	None posted
Aug 8, 2019	Supplement 43Labeling · Standard review	Approved	None posted
Aug 8, 2019	Supplement 39Labeling · Standard review	Approved	None posted
Oct 8, 2015	Supplement 33Labeling · Standard review	Approved	None posted
Nov 5, 2014	Supplement 31Labeling · Standard review	Approved	None posted
Nov 20, 2012	Supplement 27Labeling · Standard review	Approved	None posted
Jan 9, 2012	Supplement 24Labeling	Approved	None posted
Oct 27, 2010	Supplement 18Labeling	Approved	None posted
Apr 14, 2009	Supplement 3Labeling	Approved	None posted
Nov 18, 2008	Supplement 8Labeling	Approved	None posted
Apr 25, 2008	Supplement 5Labeling	Approved	None posted
May 11, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78103
Drugs@FDA: Overview at FDA
Company: Lupin

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