NDA 017084

CURIUM

FDA Drug Application

Application #017084

Documents

• Letter: 2008-09-03
• Label: 2009-05-25
• Letter: 2009-05-29
• Label: 2008-08-29

Application Sponsors

NDA 017084

CURIUM

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

5mCi/ML

0

PHOSPHOCOL P32

CHROMIC PHOSPHATE P-32

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1977-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-08-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2008-08-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2009-05-22	STANDARD

Submissions Property Types

SUPPL	2	Null	0
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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17084
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHOSPHOCOL P32","activeIngredients":"CHROMIC PHOSPHATE P-32","strength":"5mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/22\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017084s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017084s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PHOSPHOCOL P32","submission":"CHROMIC PHOSPHATE P-32","actionType":"5mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-05-22
        )

)