Simvastatin

ANDA 76685, held by Watson Labs Teva. Simvastatin.

As of Nov 13, 2026, ANDA 76685 (Simvastatin), held by Watson Labs Teva, was first approved by FDA on Dec 20, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2006
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
Dec 20, 2006	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
Aug 5, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Oct 31, 2008	Supplement 8Labeling	Approved	None posted
Jun 18, 2008	Supplement 7Labeling	Approved	None posted
Aug 14, 2007	Supplement 4Labeling	Approved	None posted
Dec 20, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 76685
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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