Rizatriptan Benzoate

ANDA 77526, held by Chartwell Rx. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 77526 (Rizatriptan Benzoate), held by Chartwell Rx, was first approved by FDA on Mar 26, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 26, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 26, 2013	Original application	Approved	None posted

Products

2 strengths and forms


Rizatriptan BenzoateEQ 5MG BASE · tablet;oral	Rizatriptan Benzoate	Rx
Rizatriptan BenzoateEQ 10MG BASE · tablet;oral	Rizatriptan Benzoate	Rx

All 3 submissions, including labeling and manufacturing supplements


Jan 29, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Nov 27, 2015	Supplement 1Manufacturing	Approved	None posted
Mar 26, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 77526
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