NDA 017653

GE HEALTHCARE

FDA Drug Application

Application #017653

Application Sponsors

NDA 017653

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

CINTICHEM TECHNETIUM 99M HEDSPA

TECHNETIUM TC-99M ETIDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	1977-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-10-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	1980-02-02	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17653
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CINTICHEM TECHNETIUM 99M HEDSPA","activeIngredients":"TECHNETIUM TC-99M ETIDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CINTICHEM TECHNETIUM 99M HEDSPA","submission":"TECHNETIUM TC-99M ETIDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)