NDA 007707

ABBVIE

FDA Drug Application

Application #007707

Application Sponsors

NDA 007707

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

PHENURONE

PHENACEMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1951-06-28	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1980-02-26	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1982-02-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-09-07	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7707
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENURONE","activeIngredients":"PHENACEMIDE","strength":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENURONE","submission":"PHENACEMIDE","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)