NDA 019212

B BRAUN

FDA Drug Application

Application #019212

Application Sponsors

NDA 019212

B BRAUN

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	200MG/100ML	0	THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
002	INJECTABLE;INJECTION	400MG/100ML	0	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
003	INJECTABLE;INJECTION	4MG/ML	0	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1984-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-04-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19212
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"400MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"4MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)