Ranolazine

Treats chronic angina. ANDA 214035, held by Vkt Pharma. Ranolazine.

As of Nov 14, 2026, ANDA 214035 (Ranolazine), held by Vkt Pharma, was first approved by FDA on Jan 19, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 19, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Ranolazine extended-release tablets is 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 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 2 submissions below

Date	Submission	Status	Documents
Jan 19, 2022	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 2 submissions, including labeling and manufacturing supplements


Jul 14, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jan 19, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 214035
Drugs@FDA: Overview at FDA
Company: VKT 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