NDA 017243

CURIUM

FDA Drug Application

Application #017243

Documents

• Letter: 2004-06-29
• Letter: 2004-10-22
• Letter: 2013-12-24
• Letter: 2015-05-05
• Label: 2004-10-22
• Letter: 2006-04-05
• Letter: 2014-02-19
• Label: 2014-02-19
• Label: 2014-01-13
• Label: 2015-05-06

Application Sponsors

NDA 017243

CURIUM

Marketing Status

• Discontinued: 002
• Prescription: 003

Application Products

002	SOLUTION;INTRAVENOUS	0.25-3 CI/GENERATOR	0	ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
003	SOLUTION;INTRAVENOUS	1-19 CI/GENERATOR	1	ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1973-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-06-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	1984-03-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-06-18	STANDARD
LABELING; Labeling	SUPPL	16	AP	1998-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-04-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2003-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2004-10-15	STANDARD
LABELING; Labeling	SUPPL	28	AP	2006-03-27	STANDARD
LABELING; Labeling	SUPPL	30	AP	2008-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2013-06-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2013-05-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2013-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2013-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2013-11-18	STANDARD
LABELING; Labeling	SUPPL	43	AP	2014-02-18	STANDARD
LABELING; Labeling	SUPPL	44	AP	2013-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2015-02-16	STANDARD
LABELING; Labeling	SUPPL	46	AP	2015-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2017-01-30	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	7
SUPPL	44	Null	7
SUPPL	45	Null	0
SUPPL	46	Null	15

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17243
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRA-TECHNEKOW FM","activeIngredients":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","strength":"0.25-3 CI\/GENERATOR","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ULTRA-TECHNEKOW FM","activeIngredients":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","strength":"1-19 CI\/GENERATOR","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/04\/2015","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/017243Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/017243s043lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2013","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017243Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2004","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17243s025lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"ULTRA-TECHNEKOW FM","submission":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","actionType":"0.25-3 CI\/GENERATOR","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ULTRA-TECHNEKOW FM","submission":"TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR","actionType":"1-19 CI\/GENERATOR","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-05-04
        )

)