NDA 019862

GE HEALTHCARE

FDA Drug Application

Application #019862

Documents

• Letter: 2004-03-16
• Letter: 2004-03-16
• Label: 2004-03-16
• Label: 2004-03-16

Application Sponsors

NDA 019862

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

2mCi/0.2ML

1

INDICLOR

INDIUM IN-111 CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1992-12-29	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1996-10-28	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2002-02-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-04-24	STANDARD
LABELING; Labeling	SUPPL	14	AP	2003-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-06-20	STANDARD

Submissions Property Types

SUPPL

21

Null

0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19862
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDICLOR","activeIngredients":"INDIUM IN-111 CHLORIDE","strength":"2mCi\/0.2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/24\/2003","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/in111med042403LB.pdf\"}]","notes":""},{"actionDate":"02\/19\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/in111med021902LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INDICLOR","submission":"INDIUM IN-111 CHLORIDE","actionType":"2mCi\/0.2ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2003-04-24
        )

)