NDA 019841

CURIUM

FDA Drug Application

Application #019841

Documents

• Label: 2004-03-16
• Letter: 2004-03-16

Application Sponsors

NDA 019841

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5mCi/0.5ML

1

INDIUM IN 111 CHLORIDE

INDIUM IN-111 CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-09-27	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1996-07-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2017-01-26	STANDARD

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19841
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDIUM IN 111 CHLORIDE","activeIngredients":"INDIUM IN-111 CHLORIDE","strength":"5mCi\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/19\/2002","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/in111mal021902LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"INDIUM IN 111 CHLORIDE","submission":"INDIUM IN-111 CHLORIDE","actionType":"5mCi\/0.5ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2002-02-19
        )

)