NDA 017995

B BRAUN

FDA Drug Application

Application #017995

Application Sponsors

NDA 017995

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	60GM/100ML	0	DEXTROSE 60% IN PLASTIC CONTAINER	DEXTROSE
002	INJECTABLE;INJECTION	60GM/100ML	0	DEXTROSE 60%	DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1978-04-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-09-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-05-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17995
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 60%","activeIngredients":"DEXTROSE","strength":"60GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEXTROSE 60% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"60GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 60%","submission":"DEXTROSE","actionType":"60GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEXTROSE 60% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"60GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)