NDA 020884

BOEHRINGER INGELHEIM

FDA Drug Application

Application #020884

Documents

• Letter: 2001-04-23
• Letter: 2004-02-02
• Letter: 2007-03-31
• Letter: 2006-12-04
• Letter: 2009-10-05
• Letter: 2012-09-11
• Label: 2003-04-24
• Label: 2007-03-31
• Label: 2006-12-04
• Letter: 2003-04-30
• Letter: 2015-11-13
• Label: 2003-04-30
• Label: 2009-10-14
• Label: 2012-09-11
• Label: 2015-11-12
• Review: 2003-04-30
• Label: 2018-11-13
• Letter: 2018-11-15
• Letter: 2019-12-12
• Label: 2020-01-10
• Label: 2021-05-17
• Letter: 2021-05-17

Application Sponsors

NDA 020884

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

25MG;200MG

1

AGGRENOX

ASPIRIN; DIPYRIDAMOLE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1999-11-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-10-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-04-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-09-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-02-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-06-20	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2004-01-28	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2007-03-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2006-11-28	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2009-10-01	STANDARD
LABELING; Labeling	SUPPL	30	AP	2012-09-07	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-05-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2014-05-30	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2015-11-09	STANDARD
LABELING; Labeling	SUPPL	37	AP	2018-11-09	STANDARD
LABELING; Labeling	SUPPL	39	AP	2019-12-11	STANDARD
LABELING; Labeling	SUPPL	40	AP	2021-05-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	18	Null	7
SUPPL	30	Null	7
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	15
SUPPL	37	Null	15
SUPPL	39	Null	7
SUPPL	40	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20884
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AGGRENOX","activeIngredients":"ASPIRIN; DIPYRIDAMOLE","strength":"25MG;200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020884s039lbledt.pdf\"}]","notes":""},{"actionDate":"11\/09\/2018","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020884s037lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2015","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020884s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020884s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2009","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020884s018lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2007","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020884s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2006","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020884s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2001","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20884s1lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20884_AGGRENOX_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AGGRENOX","submission":"ASPIRIN; DIPYRIDAMOLE","actionType":"25MG;200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-11
        )

)