NDA 019008

HOSPIRA INC

FDA Drug Application

Application #019008

Application Sponsors

NDA 019008

HOSPIRA INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	800MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE
002	INJECTABLE;INJECTION	200MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE
003	INJECTABLE;INJECTION	400MG/100ML	0	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1986-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-07-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	1994-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-06-12	STANDARD
LABELING; Labeling	SUPPL	19	AP	1999-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-06-29	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19008
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"800MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"BRETYLIUM TOSYLATE","strength":"400MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"800MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"BRETYLIUM TOSYLATE","actionType":"400MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)