Simvastatin

ANDA 90383, held by Micro Labs. Simvastatin.

As of Nov 13, 2026, ANDA 90383 (Simvastatin), held by Micro Labs, was first approved by FDA on Sep 16, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2011
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 16, 2011	Original application	Approved	None posted

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 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 26, 2023	Supplement 16Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 12Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 13Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 14Labeling · Standard review	Approved	None posted
May 23, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Jun 15, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Aug 22, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 14, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Nov 14, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Nov 4, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Nov 4, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Dec 29, 2012	Supplement 1Labeling	Approved	None posted
Sep 16, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90383
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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