NDA 017693

GE HEALTHCARE

FDA Drug Application

Application #017693

Documents

• Letter: 2015-08-11
• Label: 2015-09-09
• Letter: 2014-10-15
• Label: 2014-10-15
• Other: 2013-12-17

Application Sponsors

NDA 017693

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION;INTRAVENOUS, ORAL	830-16600mCi/GENERATOR	0	TECHNETIUM TC 99M GENERATOR	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
002	SOLUTION;INTRAVENOUS, ORAL	68-2703mCi/GENERATOR	1	TECHNETIUM TC 99M GENERATOR	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-01-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	1978-02-13
LABELING; Labeling	SUPPL	5	AP	1979-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1978-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-12-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	1982-06-07
EFFICACY; Efficacy	SUPPL	9	AP	1983-02-09
LABELING; Labeling	SUPPL	10	AP	1984-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-06-01	STANDARD
LABELING; Labeling	SUPPL	13	AP	1987-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1990-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1993-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-12-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2014-10-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2015-01-05	STANDARD
LABELING; Labeling	SUPPL	29	AP	2015-08-07	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	0
SUPPL	29	Null	7

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17693
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M GENERATOR","activeIngredients":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","strength":"830-16600mCi\/GENERATOR","dosageForm":"SOLUTION;INTRAVENOUS, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TECHNETIUM TC 99M GENERATOR","activeIngredients":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","strength":"68-2703mCi\/GENERATOR","dosageForm":"SOLUTION;INTRAVENOUS, ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/07\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/017693s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017693s026lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M GENERATOR","submission":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","actionType":"830-16600mCi\/GENERATOR","submissionClassification":"SOLUTION;INTRAVENOUS, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TECHNETIUM TC 99M GENERATOR","submission":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","actionType":"68-2703mCi\/GENERATOR","submissionClassification":"SOLUTION;INTRAVENOUS, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-08-07
        )

)