Aggrenox

NDA 20884, held by Boehringer Ingelheim. Aspirin; Dipyridamole.

As of Nov 13, 2026, NDA 20884 (Aggrenox), held by Boehringer Ingelheim, was first approved by FDA on Nov 22, 1999, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1999
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Oct 1, 2009	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 26, 2007	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 22, 1999	Original applicationNew combination · Priority review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aggrenox25MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Aspirin; Dipyridamole	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


May 13, 2021	Supplement 40Labeling · Standard review	Approved	Label Letter
Dec 11, 2019	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 9, 2018	Supplement 37Labeling · Standard review	Approved	Letter Label
Nov 9, 2015	Supplement 35Labeling · Standard review	Approved	Letter Label
May 30, 2014	Supplement 33Manufacturing · Priority review	Approved	None posted
May 29, 2013	Supplement 32Manufacturing · Priority review	Approved	None posted
Sep 7, 2012	Supplement 30Labeling	Approved	Letter Label
Oct 1, 2009	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 26, 2007	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 28, 2006	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 28, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Jun 20, 2002	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 8, 2002	Supplement 5Manufacturing · Priority review	Approved	None posted
Sep 21, 2001	Supplement 4Manufacturing · Priority review	Approved	None posted
Aug 10, 2001	Supplement 1Labeling · Standard review	Approved	Label
Apr 23, 2001	Supplement 3Manufacturing · Priority review	Approved	Letter
Oct 17, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
Nov 22, 1999	Original applicationNew combination · Priority review	Approved	Letter Label Review

Identifiers

Application: NDA 20884
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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