NDA 018150

CURIUM

FDA Drug Application

Application #018150

Documents

• Letter: 2011-06-27
• Letter: 2012-01-18
• Letter: 2016-07-14
• Letter: 2004-07-28
• Letter: 2004-04-20
• Label: 2004-07-28
• Label: 2011-06-29
• Label: 2012-01-26
• Review: 2006-10-26
• Label: 2017-03-31

Application Sponsors

NDA 018150

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1mCi/ML

1

THALLOUS CHLORIDE TL 201

THALLOUS CHLORIDE TL-201

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-10-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-09-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	1988-07-13
EFFICACY; Efficacy	SUPPL	10	AP	1993-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-03-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	1997-02-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	1999-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-06-03	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2004-07-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2004-04-16	STANDARD
LABELING; Labeling	SUPPL	25	AP	2011-06-22	UNKNOWN
LABELING; Labeling	SUPPL	26	AP	2012-01-12	UNKNOWN
LABELING; Labeling	SUPPL	27	AP	2016-07-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	31
SUPPL	20	Null	0
SUPPL	25	Null	7
SUPPL	26	Null	15
SUPPL	27	Null	6

TE Codes

001

Prescription

AP

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18150
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"THALLOUS CHLORIDE TL 201","activeIngredients":"THALLOUS CHLORIDE TL-201","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/13\/2016","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018150s027lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/018150s026lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018150s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2004","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18150s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"THALLOUS CHLORIDE TL 201","submission":"THALLOUS CHLORIDE TL-201","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-07-13
        )

)