NDA 017784

GE HEALTHCARE

FDA Drug Application

Application #017784

Application Sponsors

NDA 017784

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INJECTION, ORAL

N/A

0

TECHNETIUM TC 99M TSC

TECHNETIUM TC-99M SULFUR COLLOID KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1977-08-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	1977-09-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	1977-09-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	1979-10-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	1978-08-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	1982-08-12	STANDARD
LABELING; Labeling	SUPPL	11	AP	1981-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-12-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	1982-12-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	1985-04-19	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	1987-07-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1989-02-17	STANDARD
LABELING; Labeling	SUPPL	19	AP	1988-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17784
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M TSC","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":"TECHNETIUM TC 99M TSC","submission":"TECHNETIUM TC-99M SULFUR COLLOID KIT","actionType":"N\/A","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)