Frova

NDA 21006, held by Endo Operations. Frovatriptan Succinate.

As of Nov 14, 2026, NDA 21006 (Frova), held by Endo Operations, was first approved by FDA on Nov 8, 2001, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2001
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 8, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
FrovaEQ 2.5MG BASE · tablet;oral	Frovatriptan Succinate	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Aug 20, 2018	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 15, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 30, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 11, 2013	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 27, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 3, 2009	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 3, 2009	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 3, 2009	Supplement 10Labeling · Standard review	Approved	Label Letter
Sep 26, 2005	Supplement 5Labeling · Standard review	Approved	None posted
Nov 8, 2001	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21006
Drugs@FDA: Overview at FDA
Company: Endo Operations

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