NDA 020314

CURIUM

FDA Drug Application

Application #020314

Documents

• Letter: 2021-12-27
• Label: 2021-12-27
• Letter: 2022-02-10
• Label: 2022-02-11

Application Sponsors

NDA 020314

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3mCi/ML

1

OCTREOSCAN

INDIUM IN-111 PENTETREOTIDE KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-06-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-04-08	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2022-02-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-12-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	12	Null	7
SUPPL	14	Null	15

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20314
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"OCTREOSCAN","activeIngredients":"INDIUM IN-111 PENTETREOTIDE KIT","strength":"3mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/09\/2022","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/020314Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2021","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020314S014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OCTREOSCAN","submission":"INDIUM IN-111 PENTETREOTIDE KIT","actionType":"3mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-02-09
        )

)