NDA 018889

ABBOTT

FDA Drug Application

Application #018889

Application Sponsors

NDA 018889

ABBOTT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

500MG/100ML

0

METRONIDAZOLE

METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	1983-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-04-03
LABELING; Labeling	SUPPL	8	AP	1989-08-17
LABELING; Labeling	SUPPL	9	AP	1989-11-20
LABELING; Labeling	SUPPL	10	AP	1993-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-09-20

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18889
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METRONIDAZOLE","submission":"METRONIDAZOLE","actionType":"500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)