Altoprev

As of Nov 15, 2026, NDA 21316 (Altoprev), held by Azurity, was first approved by FDA on Jun 26, 2002, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 26, 2002
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Sep 11, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 26, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Altoprev10MG · tablet, extended release;oral	Lovastatin	Discontinued
Altoprev20MG · tablet, extended release;oral	Lovastatin	DiscontinuedReference drug
Altoprev40MG · tablet, extended release;oral	Lovastatin	DiscontinuedReference drug
Altoprev60MG · tablet, extended release;oral	Lovastatin	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Mar 14, 2024	Supplement 37Labeling · Standard review	Approved	Label
Sep 25, 2020	Supplement 36Labeling	Approved	Label Letter
Feb 28, 2018	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 4, 2017	Supplement 34Labeling · Standard review	Approved	Label Letter
Sep 14, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
May 18, 2015	Supplement 32Manufacturing · Standard review	Approved	None posted
Apr 30, 2014	Supplement 31Labeling · Standard review	Approved	Label Letter
May 15, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 21, 2012	Supplement 28Labeling	Approved	Label Letter
Oct 31, 2012	Supplement 29Labeling	Approved	Letter Label
Apr 26, 2012	Supplement 26Labeling	Approved	Letter Label
Feb 1, 2007	Supplement 18Labeling · Standard review	Approved	Letter
Jul 21, 2004	Supplement 10Labeling · Standard review	Approved	Letter Label
Sep 24, 2003	Supplement 6Labeling · Standard review	Approved	Review Letter Label
Aug 20, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Dec 18, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 11, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 26, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21316
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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