NDA 017630

GE HEALTHCARE

FDA Drug Application

Application #017630

Documents

• Letter: 2005-06-21

Application Sponsors

NDA 017630

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE;ORAL	100uCi	0	SODIUM IODIDE I 123	SODIUM IODIDE I-123
002	SOLUTION;ORAL	2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	SODIUM IODIDE I 123	SODIUM IODIDE I-123
003	CAPSULE;ORAL	200uCi	0	SODIUM IODIDE I 123	SODIUM IODIDE I-123

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1976-03-24	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1977-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-07-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-05-06	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1986-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-10-01	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1988-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-01-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-03-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-02-28	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2005-06-15	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17630
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM IODIDE I 123","activeIngredients":"SODIUM IODIDE I-123","strength":"100uCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM IODIDE I 123","activeIngredients":"SODIUM IODIDE I-123","strength":"2mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM IODIDE I 123","submission":"SODIUM IODIDE I-123","actionType":"100uCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM IODIDE I 123","submission":"SODIUM IODIDE I-123","actionType":"2mCi\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)