NDA 017059

MALLINCKRODT

FDA Drug Application

Application #017059

Application Sponsors

NDA 017059

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INJECTION, ORAL

N/A

0

TECHNECOLL

TECHNETIUM TC-99M SULFUR COLLOID KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-09-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	1976-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-12-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	1982-10-19
EFFICACY; Efficacy	SUPPL	9	AP	1984-09-06
EFFICACY; Efficacy	SUPPL	10	AP	1985-09-09
LABELING; Labeling	SUPPL	11	AP	1989-02-10

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17059
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNECOLL","activeIngredients":"TECHNETIUM TC-99M SULFUR COLLOID KIT","strength":"N\/A","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNECOLL","submission":"TECHNETIUM TC-99M SULFUR COLLOID KIT","actionType":"N\/A","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)