Ranexa

NDA 21526, held by Menarini Intl. Ranolazine.

As of Nov 14, 2026, NDA 21526 (Ranexa), held by Menarini Intl, was first approved by FDA on Jan 27, 2006, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2006
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Nov 5, 2008	Supplement 4Efficacy (new indication or use)	Approved	Review Label Letter
Jan 27, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Ranexa1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ranolazine	DiscontinuedReference drug
Ranexa500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Ranolazine	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements


Oct 29, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 7, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Apr 22, 2016	Supplement 33Manufacturing · Standard review	Approved	None posted
Jan 6, 2016	Supplement 29Labeling · Standard review	Approved	Label Letter
Dec 15, 2015	Supplement 28Labeling · Standard review	Approved	Label Letter
Nov 10, 2015	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 17, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 19, 2013	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 12, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 25, 2012	Supplement 22Labeling	Approved	Letter Label
Dec 21, 2011	Supplement 18Labeling · Standard review	Approved	Letter Label
Jul 11, 2011	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 23, 2010	Supplement 12Labeling	Approved	Label Letter
Mar 26, 2009	Supplement 7Manufacturing	Approved	Review Letter Label
Nov 5, 2008	Supplement 4Efficacy (new indication or use)	Approved	Review Label Letter
Dec 17, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 27, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21526
Drugs@FDA: Overview at FDA
Company: Menarini Intl

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