NDA 050796

B BRAUN

FDA Drug Application

Application #050796

Documents

• Letter: 2005-04-28
• Letter: 2007-09-11
• Letter: 2008-12-19
• Letter: 2010-06-30
• Letter: 2013-04-16
• Letter: 2015-07-13
• Label: 2005-04-28
• Label: 2013-04-16
• Label: 2015-07-10
• Letter: 2008-12-19
• Letter: 2012-02-07
• Letter: 2013-03-13
• Label: 2007-09-11
• Label: 2012-02-07
• Label: 2010-07-01
• Label: 2013-03-11
• Review: 2007-07-02
• Letter: 2020-09-10
• Label: 2020-09-10
• Letter: 2021-03-10
• Label: 2021-03-10
• Label: 2022-01-14
• Letter: 2022-01-18

Application Sponsors

NDA 050796

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	1	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM
002	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	1	CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER	CEFTRIAXONE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2005-04-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-09-10	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-05-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-05-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-01-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2010-06-25	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2013-03-11	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2013-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-02-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2015-07-09	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	23	AP	2020-09-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2021-03-09	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	14	Null	7
SUPPL	17	Null	6
SUPPL	18	Null	0
SUPPL	19	Null	15
SUPPL	23	Null	6
SUPPL	25	Null	7
SUPPL	30	Null	6

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50796
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFTRIAXONE SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/09\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050796Orig1s019lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/10\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050796s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050796s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2012","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050796Orig1s011lbledt.pdf\"}]","notes":""},{"actionDate":"06\/25\/2010","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050796s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050796s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/050796lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFTRIAXONE SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-07-09
        )

)