NDA 017725

MALLINCKRODT

FDA Drug Application

Application #017725

Application Sponsors

NDA 017725

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INJECTION, ORAL

10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

SODIUM PERTECHNETATE TC 99M

TECHNETIUM TC-99M SODIUM PERTECHNETATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1977-12-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	1979-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-04-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	1982-10-05
LABELING; Labeling	SUPPL	5	AP	1986-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-07-20	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	1986-09-09

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17725
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PERTECHNETATE TC 99M","activeIngredients":"TECHNETIUM TC-99M SODIUM PERTECHNETATE","strength":"10-60mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM PERTECHNETATE TC 99M","submission":"TECHNETIUM TC-99M SODIUM PERTECHNETATE","actionType":"10-60mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)