NDA 006800

ABBVIE

FDA Drug Application

Application #006800

Application Sponsors

NDA 006800

ABBVIE

Marketing Status

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

Application Products

001	CAPSULE;ORAL	300MG	0	PARADIONE	PARAMETHADIONE
002	SOLUTION;ORAL	300MG/ML	0	PARADIONE	PARAMETHADIONE
003	CAPSULE;ORAL	150MG	0	PARADIONE	PARAMETHADIONE

FDA Submissions

	ORIG	1	AP	1949-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1975-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-10-24
LABELING; Labeling	SUPPL	10	AP	1980-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-03-24

Submissions Property Types

ORIG	1	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6800
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARADIONE","activeIngredients":"PARAMETHADIONE","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PARADIONE","activeIngredients":"PARAMETHADIONE","strength":"300MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PARADIONE","activeIngredients":"PARAMETHADIONE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PARADIONE","submission":"PARAMETHADIONE","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PARADIONE","submission":"PARAMETHADIONE","actionType":"300MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PARADIONE","submission":"PARAMETHADIONE","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)