Ranolazine

Treats chronic angina. ANDA 211082, held by Glenmark Pharms Ltd. Ranolazine.

As of Nov 14, 2026, ANDA 211082 (Ranolazine), held by Glenmark Pharms Ltd, was first approved by FDA on Jul 5, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 5, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. 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 3 submissions below

Date	Submission	Status	Documents
Jul 5, 2019	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jan 29, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jan 29, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jul 5, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 211082
Drugs@FDA: Overview at FDA
Company: Glenmark 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