NDA 019882

CURIUM

FDA Drug Application

Application #019882

Application Sponsors

NDA 019882

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

1

TECHNESCAN MAG3

TECHNETIUM TC-99M MERTIATIDE KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-06-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	1993-02-26
LABELING; Labeling	SUPPL	3	AP	1992-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-07-28	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AP

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19882
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNESCAN MAG3","activeIngredients":"TECHNETIUM TC-99M MERTIATIDE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNESCAN MAG3","submission":"TECHNETIUM TC-99M MERTIATIDE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)