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FDA NDA · NDA020884

AGGRENOX

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020884
TYPE
NDA
ORIGINAL APPROVAL
1999-11-22
LATEST ACTION
2021-05-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

AGGRENOX · ReferenceDiscontinued
ASPIRIN 25MG, DIPYRIDAMOLE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2021-05-13Labeling · Supplement 40 · standard — Label ↗AP
2019-12-11Labeling · Supplement 39 · standard — Letter ↗AP
2018-11-09Labeling · Supplement 37 · standard — Label ↗AP
2015-11-09Labeling · Supplement 35 · standard — Letter ↗AP
2014-05-30Manufacturing (CMC) · Supplement 33 · priorityAP
2013-05-29Manufacturing (CMC) · Supplement 32 · priorityAP
2012-09-07Labeling · Supplement 30 · unknown — Letter ↗AP
2009-10-01Efficacy · Supplement 18 · standard — Letter ↗AP
2007-03-26Efficacy · Supplement 12 · standard — Label ↗AP
2006-11-28Labeling · Supplement 14 · standard — Label ↗AP
2004-01-28Labeling · Supplement 7 · standard — Letter ↗AP
2002-06-20Manufacturing (CMC) · Supplement 6 · priorityAP
2002-02-08Manufacturing (CMC) · Supplement 5 · priorityAP
2001-09-21Manufacturing (CMC) · Supplement 4 · priorityAP
2001-08-10Labeling · Supplement 1 · standard — Label ↗AP
2001-04-23Manufacturing (CMC) · Supplement 3 · priority — Letter ↗AP
2000-10-17Manufacturing (CMC) · Supplement 2 · priorityAP
1999-11-22Type 4 - New Combination · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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