NDA 019044

GE HEALTHCARE

FDA Drug Application

Application #019044

Documents

• Letter: 2002-09-19
• Label: 2014-11-18
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2011-02-15
• Review: 2012-03-27
• Review: 2012-03-27
• Review: 2011-02-15
• Letter: 2022-12-13
• Label: 2022-12-13

Application Sponsors

NDA 019044

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1mCi/ML

1

INDIUM IN 111 OXYQUINOLINE

INDIUM IN-111 OXYQUINOLINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-12-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-12-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-06-08	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1989-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-08-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-08-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-08-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-08-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-08-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-01-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-08-11	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1997-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-08-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-08-30	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2002-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2013-11-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2014-07-07	PRIORITY
LABELING; Labeling	SUPPL	25	TA	2022-06-17	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

TE Codes

001

Prescription

AP

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19044
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDIUM IN 111 OXYQUINOLINE","activeIngredients":"INDIUM IN-111 OXYQUINOLINE","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/24\/1985","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/pre96\\\/019044Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INDIUM IN 111 OXYQUINOLINE","submission":"INDIUM IN-111 OXYQUINOLINE","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1985-12-24
        )

)