NDA 017538

CURIUM

FDA Drug Application

Application #017538

Documents

• Label: 2017-03-22
• Letter: 2017-03-24

Application Sponsors

NDA 017538

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

TECHNESCAN PYP KIT

TECHNETIUM TC-99M PYROPHOSPHATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-05-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1976-01-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	1977-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-08-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	1978-11-09
LABELING; Labeling	SUPPL	8	AP	1978-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-05-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	1984-05-21
EFFICACY; Efficacy	SUPPL	11	AP	1989-01-30
LABELING; Labeling	SUPPL	12	AP	1988-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2007-02-26	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2013-11-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-03-21	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	15

TE Codes

001

Prescription

AP

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17538
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNESCAN PYP KIT","activeIngredients":"TECHNETIUM TC-99M PYROPHOSPHATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/21\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017538s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TECHNESCAN PYP KIT","submission":"TECHNETIUM TC-99M PYROPHOSPHATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-03-21
        )

)