Ranolazine

Treats chronic angina. ANDA 201046, held by Chartwell Rx. Ranolazine.

As of Nov 14, 2026, ANDA 201046 (Ranolazine), held by Chartwell Rx, was first approved by FDA on Jul 29, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2013
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 29, 2013	Original application	Approved	Letter

Products

2 strengths and forms


Ranolazine500MG · tablet, extended release;oral	Ranolazine	Rx
Ranolazine1GM · tablet, extended release;oral	Ranolazine	Rx

All 6 submissions, including labeling and manufacturing supplements


Aug 18, 2020	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 25, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Feb 25, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Feb 25, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Feb 25, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jul 29, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 201046
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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