NDA 016708

CURIUM

FDA Drug Application

Application #016708

Application Sponsors

NDA 016708

CURIUM

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100uCi/ML

0

SODIUM CHROMATE CR 51

SODIUM CHROMATE CR-51

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1971-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1975-06-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1977-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1980-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-05-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	1984-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-06-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	1995-10-25	STANDARD
LABELING; Labeling	SUPPL	14	AP	1997-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-08-28	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16708
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM CHROMATE CR 51","activeIngredients":"SODIUM CHROMATE CR-51","strength":"100uCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM CHROMATE CR 51","submission":"SODIUM CHROMATE CR-51","actionType":"100uCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)