NDA 012836

BOEHRINGER INGELHEIM

FDA Drug Application

Application #012836

Documents

• Letter: 2005-08-03
• Letter: 2004-08-06
• Label: 2005-08-03
• Letter: 2019-12-12
• Label: 2019-12-12

Application Sponsors

NDA 012836

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

003	TABLET;ORAL	25MG	1	PERSANTINE	DIPYRIDAMOLE
004	TABLET;ORAL	50MG	1	PERSANTINE	DIPYRIDAMOLE
005	TABLET;ORAL	75MG	1	PERSANTINE	DIPYRIDAMOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1961-12-06	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	1986-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1982-10-08	STANDARD
LABELING; Labeling	SUPPL	38	AP	1986-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-02-06	STANDARD
LABELING; Labeling	SUPPL	41	AP	1988-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1988-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1989-08-30	STANDARD
LABELING; Labeling	SUPPL	45	AP	1988-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1995-02-21	STANDARD
LABELING; Labeling	SUPPL	47	AP	1991-03-26
LABELING; Labeling	SUPPL	49	AP	1994-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1994-05-18	STANDARD
LABELING; Labeling	SUPPL	51	AP	1997-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2000-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2001-05-24	STANDARD
LABELING; Labeling	SUPPL	54	AP	2004-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2002-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2002-06-20	STANDARD
LABELING; Labeling	SUPPL	57	AP	2005-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2014-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2015-07-29	STANDARD
LABELING; Labeling	SUPPL	61	AP	2019-12-11	STANDARD

Submissions Property Types

SUPPL	32	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	0
SUPPL	46	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	6

TE Codes

003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12836
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERSANTINE","activeIngredients":"DIPYRIDAMOLE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PERSANTINE","activeIngredients":"DIPYRIDAMOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PERSANTINE","activeIngredients":"DIPYRIDAMOLE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/012836s061lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2005","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/012836s057lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PERSANTINE","submission":"DIPYRIDAMOLE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PERSANTINE","submission":"DIPYRIDAMOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PERSANTINE","submission":"DIPYRIDAMOLE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-11
        )

)