NDA 018674

B BRAUN

FDA Drug Application

Application #018674

Application Sponsors

NDA 018674

B BRAUN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

500MG/100ML

0

METRO I.V.

METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	1982-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-02-22
LABELING; Labeling	SUPPL	8	AP	1988-07-08
LABELING; Labeling	SUPPL	9	AP	1989-01-25
LABELING; Labeling	SUPPL	10	AP	1990-06-22	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18674
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRO I.V.","activeIngredients":"METRONIDAZOLE","strength":"500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METRO I.V.","submission":"METRONIDAZOLE","actionType":"500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)