ANDA 078806

JUBILANT DRAXIMAGE

FDA Drug Application

Application #078806

Application Sponsors

ANDA 078806

JUBILANT DRAXIMAGE

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	2009-04-29
LABELING; Labeling	SUPPL	15	AP	2018-05-01	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

JUBILANT DRAXIMAGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78806
            [companyName] => JUBILANT DRAXIMAGE
            [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
        )

)