Ranolazine

Treats chronic angina. ANDA 210054, held by Ajanta Pharma Ltd. Ranolazine.

As of Nov 14, 2026, ANDA 210054 (Ranolazine), held by Ajanta Pharma Ltd, was first approved by FDA on May 28, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: May 28, 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 is 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
May 28, 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


Feb 24, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Oct 31, 2019	Supplement 4Labeling · Standard review	Approved	None posted
May 28, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210054
Drugs@FDA: Overview at FDA
Company: Ajanta Pharma

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