Rizatriptan Benzoate

ANDA 204090, held by Avet Lifesciences. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 204090 (Rizatriptan Benzoate), held by Avet Lifesciences, was first approved by FDA on Nov 26, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 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
Nov 26, 2013	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 29, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Nov 26, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 204090
Drugs@FDA: Overview at FDA
Company: Avet Lifesciences

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