NDA 019829

GE HEALTHCARE

FDA Drug Application

Application #019829

Documents

• Letter: 2013-08-06
• Letter: 2005-06-21
• Label: 2013-08-05
• Label: 2018-09-20
• Letter: 2018-10-01

Application Sponsors

NDA 019829

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

1

CERETEC

TECHNETIUM TC-99M EXAMETAZIME KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1988-12-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-04-07	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	1995-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-04-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-07-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-11-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-09-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-04-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-08-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-11-25	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2005-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-03-08	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2013-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-06-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2016-04-08	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2018-09-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	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	14	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	34	Null	7

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19829
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CERETEC","activeIngredients":"TECHNETIUM TC-99M EXAMETAZIME KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/19\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019829s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019829s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019829s026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CERETEC","submission":"TECHNETIUM TC-99M EXAMETAZIME KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-09-19
        )

)