NDA 017707

GE HEALTHCARE

FDA Drug Application

Application #017707

Documents

• Letter: 2004-09-27

Application Sponsors

NDA 017707

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRATHECAL

1mCi/ML

1

MPI INDIUM DTPA IN 111

INDIUM IN-111 PENTETATE DISODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-09-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	1985-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-02-28	STANDARD
LABELING; Labeling	SUPPL	7	AP	1996-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-04-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-12-22	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17707
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MPI INDIUM DTPA IN 111","activeIngredients":"INDIUM IN-111 PENTETATE DISODIUM","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MPI INDIUM DTPA IN 111","submission":"INDIUM IN-111 PENTETATE DISODIUM","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)