NDA 019981

CURIUM

FDA Drug Application

Application #019981

Application Sponsors

NDA 019981

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

1

ULTRATAG

TECHNETIUM TC-99M RED BLOOD CELL KIT

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-09-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	1998-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-09-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19981
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRATAG","activeIngredients":"TECHNETIUM TC-99M RED BLOOD CELL KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ULTRATAG","submission":"TECHNETIUM TC-99M RED BLOOD CELL KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)