Ranolazine

ANDA 212889, held by Rising. Ranolazine.

As of Nov 14, 2026, ANDA 212889 (Ranolazine), held by Rising, was first approved by FDA on Jan 28, 2021, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 28, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 28, 2021	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 1, 2022	Supplement 2Manufacturing	Approved	None posted
Jan 28, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 212889
Drugs@FDA: Overview at FDA
Company: Rising 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