NDA 018900

B BRAUN

FDA Drug Application

Application #018900

Documents

• Letter: 2015-12-10
• Letter: 2015-07-14
• Label: 2015-12-10
• Label: 2015-07-16
• Label: 2018-04-12
• Letter: 2018-04-16
• Letter: 2021-03-09
• Label: 2021-03-09
• Label: 2021-04-30
• Letter: 2021-04-30
• Label: 2021-12-17
• Letter: 2021-12-20

Application Sponsors

NDA 018900

B BRAUN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/100ML

1

METRO I.V. IN PLASTIC CONTAINER

METRONIDAZOLE

FDA Submissions

	ORIG	1	AP	1983-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-03-11
LABELING; Labeling	SUPPL	7	AP	1988-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-09-01
LABELING; Labeling	SUPPL	10	AP	1989-01-25
LABELING; Labeling	SUPPL	11	AP	1991-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-11-06
LABELING; Labeling	SUPPL	14	AP	1993-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-07-08
LABELING; Labeling	SUPPL	23	AP	2004-02-20
LABELING; Labeling	SUPPL	25	AP	2007-07-21
LABELING; Labeling	SUPPL	27	AP	2008-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2014-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2014-03-25
LABELING; Labeling	SUPPL	31	AP	2015-12-08	STANDARD
LABELING; Labeling	SUPPL	32	AP	2015-07-13	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	35	AP	2018-04-11	STANDARD
LABELING; Labeling	SUPPL	38	AP	2021-04-29	STANDARD
LABELING; Labeling	SUPPL	39	AP	2021-03-05	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-12-15	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	15
SUPPL	32	Null	6
SUPPL	35	Null	15
SUPPL	38	Null	6
SUPPL	39	Null	15
SUPPL	41	Null	7

TE Codes

001

Prescription

AP

CDER Filings

B BRAUN

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        (
            [ApplNo] => 18900
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRO I.V. IN PLASTIC CONTAINER","activeIngredients":"METRONIDAZOLE","strength":"500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/11\/2018","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018900s035lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018900s031lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2015","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018900s032lbl.pdf\"}]","notes":"Please see"}]
            [originalApprovals] => [{"actionDate":"METRO I.V. IN PLASTIC CONTAINER","submission":"METRONIDAZOLE","actionType":"500MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-11
        )

)