Rizatriptan Benzoate

ANDA 203478, held by Natco Pharma Ltd. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 203478 (Rizatriptan Benzoate), held by Natco Pharma Ltd, was first approved by FDA on Jul 1, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 1, 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
Jul 1, 2013	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Sep 4, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Sep 4, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jul 1, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203478
Drugs@FDA: Overview at FDA
Company: Natco 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