NDA 065430

B BRAUN

FDA Drug Application

Application #065430

Documents

• Letter: 2007-08-14
• Label: 2020-01-31
• Letter: 2020-01-31

Application Sponsors

NDA 065430

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2007-08-09	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2013-12-18	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	9	AP	2020-01-30	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	9	Null	7

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65430
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/30\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/065430s009lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFOTETAN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER","submission":"CEFOTETAN DISODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-30
        )

)