Simvastatin

ANDA 206557, held by Invagen Pharms. Simvastatin.

As of Nov 13, 2026, ANDA 206557 (Simvastatin), held by Invagen Pharms, was first approved by FDA on Nov 13, 2017, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 13, 2017
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 13, 2017	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 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 27, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 27, 2023	Supplement 7Labeling · Standard review	Approved	None posted
May 14, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 30, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jul 30, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 13, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206557
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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