Simvastatin

ANDA 90868, held by Pharmobedient. Simvastatin.

As of Nov 13, 2026, ANDA 90868 (Simvastatin), held by Pharmobedient, was first approved by FDA on Jun 8, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 8, 2010
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 8, 2010	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 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 30, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Nov 14, 2016	Supplement 5Labeling · Standard review	Approved	None posted
May 1, 2012	Supplement 4Labeling	Approved	None posted
Jan 11, 2012	Supplement 3Labeling	Approved	None posted
Jun 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90868
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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