NDA 018335

GE HEALTHCARE

FDA Drug Application

Application #018335

Application Sponsors

NDA 018335

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

AMERSCAN MDP KIT

TECHNETIUM TC-99M MEDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1982-08-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	1988-08-24	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18335
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMERSCAN MDP KIT","activeIngredients":"TECHNETIUM TC-99M MEDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMERSCAN MDP KIT","submission":"TECHNETIUM TC-99M MEDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)