NDA 208870

JUBILANT DRAXIMAGE

FDA Drug Application

Application #208870

Documents

• Label: 2017-08-18
• Letter: 2017-08-22
• Review: 2018-04-10

Application Sponsors

NDA 208870

JUBILANT DRAXIMAGE

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

N/A

0

DRAX EXAMETAZIME

TECHNETIUM TC-99M EXAMETAZIME KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2017-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

JUBILANT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208870
            [companyName] => JUBILANT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRAX EXAMETAZIME","activeIngredients":"TECHNETIUM TC-99M EXAMETAZIME KIT","strength":"N\/A","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/17\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208870s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208870s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208870Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208870Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-08-17
        )

)