NDA 005545

ABBVIE

FDA Drug Application

Application #005545

Application Sponsors

NDA 005545

ABBVIE

Marketing Status

• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

003	TABLET;ORAL	25MG	0	DICUMAROL	DICUMAROL
004	TABLET;ORAL	50MG	0	DICUMAROL	DICUMAROL
005	TABLET;ORAL	100MG	0	DICUMAROL	DICUMAROL

FDA Submissions

	ORIG	1	AP	1944-07-31
LABELING; Labeling	SUPPL	7	AP	1975-12-18
LABELING; Labeling	SUPPL	8	AP	1977-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-06-10
LABELING; Labeling	SUPPL	13	AP	1982-08-10
LABELING; Labeling	SUPPL	14	AP	1982-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-08-14
LABELING; Labeling	SUPPL	17	AP	1987-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-04-14

Submissions Property Types

ORIG	1	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 5545
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICUMAROL","activeIngredients":"DICUMAROL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DICUMAROL","activeIngredients":"DICUMAROL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DICUMAROL","activeIngredients":"DICUMAROL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICUMAROL","submission":"DICUMAROL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DICUMAROL","submission":"DICUMAROL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DICUMAROL","submission":"DICUMAROL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)