Rizatriptan Benzoate

Treats migraine with or without aura. ANDA 203146, held by Macleods Pharms Ltd. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 203146 (Rizatriptan Benzoate), held by Macleods Pharms Ltd, was first approved by FDA on Sep 19, 2014, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 19, 2014
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use

Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.

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
Sep 19, 2014	Original application	Approved	Letter

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jun 7, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Sep 19, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 203146
Drugs@FDA: Overview at FDA
Company: Macleods 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