NDA 050792

B BRAUN

FDA Drug Application

Application #050792

Documents

• Letter: 2007-09-11
• Label: 2004-08-02
• Label: 2007-09-11
• Review: 2006-07-28
• Letter: 2004-08-02

Application Sponsors

NDA 050792

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 2GM BASE	0	CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM
002	INJECTABLE;INJECTION	EQ 1GM BASE	0	CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER	CEFOTAXIME SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2004-07-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2007-09-10	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

ORIG

1

Null

31

CDER Filings

B BRAUN

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    [0] => Array
        (
            [ApplNo] => 50792
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER","activeIngredients":"CEFOTAXIME SODIUM","strength":"EQ 2GM BASE","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER","activeIngredients":"CEFOTAXIME SODIUM","strength":"EQ 1GM BASE","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/10\/2007","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050792s002lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/29\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50792lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER","submission":"CEFOTAXIME SODIUM","actionType":"EQ 2GM BASE","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER","submission":"CEFOTAXIME SODIUM","actionType":"EQ 1GM BASE","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2007-09-10
        )

)