NDA 018321

CURIUM

FDA Drug Application

Application #018321

Documents

• Letter: 2017-04-03
• Label: 2017-04-04

Application Sponsors

NDA 018321

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

1

TECHNESCAN

TECHNETIUM TC-99M OXIDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1981-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-02-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-02-03	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	1989-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-09-30	STANDARD
LABELING; Labeling	SUPPL	15	AP	1994-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2013-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-06-17	STANDARD
LABELING; Labeling	SUPPL	22	AP	2017-03-31	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	15

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18321
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNESCAN","activeIngredients":"TECHNETIUM TC-99M OXIDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/31\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018321s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TECHNESCAN","submission":"TECHNETIUM TC-99M OXIDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-31
        )

)