ANDA 086562

ORGANON USA INC

FDA Drug Application

Application #086562

Application Sponsors

ANDA 086562

ORGANON USA INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG;1MG

0

WIGRAINE

CAFFEINE; ERGOTAMINE TARTRATE

FDA Submissions

	ORIG	1	AP	1980-11-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-01-19
LABELING; Labeling	SUPPL	10	AP	1998-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-03-07
LABELING; Labeling	SUPPL	12	AP	1993-08-31
LABELING; Labeling	SUPPL	13	AP	1993-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-05-02

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86562
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"WIGRAINE","activeIngredients":"CAFFEINE; ERGOTAMINE TARTRATE","strength":"100MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"WIGRAINE","submission":"CAFFEINE; ERGOTAMINE TARTRATE","actionType":"100MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)