NDA 017098

MALLINCKRODT

FDA Drug Application

Application #017098

Application Sponsors

NDA 017098

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100uCi/ML

0

SELENOMETHIONINE SE 75

SELENOMETHIONINE SE-75

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1973-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-10-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	1984-03-13	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17098
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELENOMETHIONINE SE 75","activeIngredients":"SELENOMETHIONINE SE-75","strength":"100uCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SELENOMETHIONINE SE 75","submission":"SELENOMETHIONINE SE-75","actionType":"100uCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)