Rizatriptan Benzoate

ANDA 203252, held by Jubilant Generics. Rizatriptan Benzoate.

As of Nov 14, 2026, ANDA 203252 (Rizatriptan Benzoate), held by Jubilant Generics, was first approved by FDA on Dec 31, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 31, 2014
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 31, 2014	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 2 submissions, including labeling and manufacturing supplements


Apr 12, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Dec 31, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203252
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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