NDA 019826

B BRAUN

FDA Drug Application

Application #019826

Documents

• Letter: 2008-04-10
• Letter: 2008-10-21
• Letter: 2012-02-27
• Label: 2012-02-22

Application Sponsors

NDA 019826

B BRAUN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Discontinued: 004
• Discontinued: 005
• Prescription: 006

Application Products

001	INJECTABLE;INJECTION	40MG/100ML	1	THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
002	INJECTABLE;INJECTION	80MG/100ML	1	THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
003	INJECTABLE;INJECTION	160MG/100ML	1	THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
004	INJECTABLE;INJECTION	200MG/100ML	0	THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
005	INJECTABLE;INJECTION	400MG/100ML	0	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE
006	INJECTABLE;INJECTION	320MG/100ML	1	THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1992-08-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-12-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	1996-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-07-12	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-04-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2008-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2014-08-22	STANDARD
LABELING; Labeling	SUPPL	23	AP	2012-02-17	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	15

CDER Filings

B BRAUN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19826
            [companyName] => B BRAUN
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"40MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"80MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"160MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"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 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"THEOPHYLLINE","strength":"320MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"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"}]
            [labels] => [{"actionDate":"02\/17\/2012","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019826s023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"40MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"80MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"160MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"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 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"320MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER","submission":"THEOPHYLLINE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-02-17
        )

)