NDA 050821

B BRAUN

FDA Drug Application

Application #050821

Documents

• Letter: 2010-05-10
• Letter: 2012-09-10
• Letter: 2015-11-13
• Label: 2010-05-17
• Summary Review: 2010-08-30
• Letter: 2014-06-10
• Label: 2012-09-11
• Label: 2014-06-10
• Label: 2015-11-13
• Review: 2010-08-30
• Letter: 2022-03-21
• Label: 2022-03-24

Application Sponsors

NDA 050821

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	CEFEPIME HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-05-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-06-06	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-11-09	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	6	AP	2022-03-18	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	4	Null	15
SUPPL	6	Null	15

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50821
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFEPIME HYDROCHLORIDE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/09\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050821s004lbl.pdf\"}]","notes":"Please see"},{"actionDate":"06\/06\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050821s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050821s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050821s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050821s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFEPIME HYDROCHLORIDE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2015-11-09
        )

)