NDA 017562

GE HEALTHCARE

FDA Drug Application

Application #017562

Application Sponsors

NDA 017562

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT

TECHNETIUM TC-99M ETIDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-08-05	STANDARD
LABELING; Labeling	SUPPL	9	AP	2001-09-17

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17562
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT","activeIngredients":"TECHNETIUM TC-99M ETIDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT","submission":"TECHNETIUM TC-99M ETIDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)