Rizatriptan Benzoate

ANDA 78173, held by Pharmobedient. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 78173 (Rizatriptan Benzoate), held by Pharmobedient, was first approved by FDA on Dec 31, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2012
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 31, 2012	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 4 submissions, including labeling and manufacturing supplements


Apr 7, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Nov 9, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Feb 10, 2015	Supplement 2Manufacturing	Approved	None posted
Dec 31, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 78173
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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