NDA 017456

GE HEALTHCARE

FDA Drug Application

Application #017456

Application Sponsors

NDA 017456

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INJECTION, ORAL

4mCi/ML

0

TECHNETIUM TC 99M SULFUR COLLOID

TECHNETIUM TC-99M SULFUR COLLOID

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-09-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	2001-09-17

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17456
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M SULFUR COLLOID","activeIngredients":"TECHNETIUM TC-99M SULFUR COLLOID","strength":"4mCi\/ML","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M SULFUR COLLOID","submission":"TECHNETIUM TC-99M SULFUR COLLOID","actionType":"4mCi\/ML","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)