Rizatriptan Benzoate

ANDA 201993, held by Pharmobedient. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 201993 (Rizatriptan Benzoate), held by Pharmobedient, was first approved by FDA on Dec 31, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 31, 2012
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
Dec 31, 2012	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


Sep 21, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Sep 21, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Dec 31, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201993
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