NDA 018058

CURIUM

FDA Drug Application

Application #018058

Application Sponsors

NDA 018058

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2mCi/ML

0

GALLIUM CITRATE GA 67

GALLIUM CITRATE GA-67

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-07-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-05-07	STANDARD
LABELING; Labeling	SUPPL	5	AP	1984-03-08
LABELING; Labeling	SUPPL	7	AP	1982-09-27
LABELING; Labeling	SUPPL	8	AP	1982-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2014-03-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0

TE Codes

001

Prescription

BS

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18058
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"GALLIUM CITRATE GA 67","activeIngredients":"GALLIUM CITRATE GA-67","strength":"2mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GALLIUM CITRATE GA 67","submission":"GALLIUM CITRATE GA-67","actionType":"2mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)