NDA 019817

BOEHRINGER INGELHEIM

FDA Drug Application

Application #019817

Application Sponsors

NDA 019817

BOEHRINGER INGELHEIM

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

IV PERSANTINE

DIPYRIDAMOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-12-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1991-06-05	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1991-04-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-04-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-12-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-03-03	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1995-06-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-05-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-10-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-10-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-02-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-06-20	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19817
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"IV PERSANTINE","activeIngredients":"DIPYRIDAMOLE","strength":"5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IV PERSANTINE","submission":"DIPYRIDAMOLE","actionType":"5MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)