Simvastatin

ANDA 76285, held by Sun Pharm Inds Ltd. Simvastatin.

As of Nov 13, 2026, ANDA 76285 (Simvastatin), held by Sun Pharm Inds Ltd, was first approved by FDA on Jun 23, 2006, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2006
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 23, 2006	Original application	Approved	Letter

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 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 5, 2009	Supplement 13Labeling	Approved	None posted
Jun 18, 2008	Supplement 9Labeling	Approved	None posted
Dec 20, 2006	Supplement 4Labeling	Approved	None posted
Dec 20, 2006	Supplement 3Manufacturing	Approved	None posted
Dec 20, 2006	Supplement 2Manufacturing	Approved	None posted
Jun 23, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 76285
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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