NDA 019002

JOHNSON AND JOHNSON

FDA Drug Application

Application #019002

Documents

• Review: 2003-08-05

Application Sponsors

NDA 019002

JOHNSON AND JOHNSON

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	200MG	0	VASCOR	BEPRIDIL HYDROCHLORIDE
002	TABLET;ORAL	300MG	0	VASCOR	BEPRIDIL HYDROCHLORIDE
003	TABLET;ORAL	400MG	0	VASCOR	BEPRIDIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-12-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-05-12	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1993-01-28	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1993-01-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-01-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-06-28	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1998-03-10	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2000-07-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-02-06	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	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

JOHNSON AND JOHNSON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19002
            [companyName] => JOHNSON AND JOHNSON
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASCOR","activeIngredients":"BEPRIDIL HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VASCOR","activeIngredients":"BEPRIDIL HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VASCOR","activeIngredients":"BEPRIDIL HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VASCOR","submission":"BEPRIDIL HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VASCOR","submission":"BEPRIDIL HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VASCOR","submission":"BEPRIDIL HYDROCHLORIDE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)