ANDA 078098

CURIUM

FDA Drug Application

Application #078098

Documents

• Review: 2012-03-28
• Letter: 2008-09-23

Application Sponsors

ANDA 078098

CURIUM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

TECHNETIUM TC 99M SESTAMIBI

TECHNETIUM TC-99M SESTAMIBI KIT

FDA Submissions

	ORIG	1	AP	2008-09-22
LABELING; Labeling	SUPPL	3	AP	2015-04-09
LABELING; Labeling	SUPPL	10	AP	2022-05-17	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

CURIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78098
            [companyName] => CURIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC 99M SESTAMIBI","activeIngredients":"TECHNETIUM TC-99M SESTAMIBI KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC 99M SESTAMIBI","submission":"TECHNETIUM TC-99M SESTAMIBI KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)