NDA 019083

B BRAUN

FDA Drug Application

Application #019083

Application Sponsors

NDA 019083

B BRAUN

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	40MG/100ML	0	THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
002	INJECTABLE;INJECTION	80MG/100ML	0	THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
003	INJECTABLE;INJECTION	160MG/100ML	0	THEOPHYLLINE 0.16% 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	2	AP	1985-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-10-15	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] => 19083
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"40MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"80MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"160MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"40MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"80MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"160MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)