NDA 017655

GE HEALTHCARE

FDA Drug Application

Application #017655

Application Sponsors

NDA 017655

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2mCi/ML

0

NEOSCAN

GALLIUM CITRATE GA-67

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1978-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-12-26	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1985-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-03-06	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17655
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOSCAN","activeIngredients":"GALLIUM CITRATE GA-67","strength":"2mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOSCAN","submission":"GALLIUM CITRATE GA-67","actionType":"2mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)