NDA 216820

JUBILANT DRAXIMAGE

FDA Drug Application

Application #216820

Documents

• Letter: 2023-01-31
• Label: 2023-01-31

Application Sponsors

NDA 216820

JUBILANT DRAXIMAGE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5-10MCI

0

TECHNETIUM TC-99M MERTIATIDE KIT

TECHNETIUM TC-99M MERTIATIDE KIT

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2023-01-30

STANDARD

CDER Filings

JUBILANT DRAXIMAGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216820
            [companyName] => JUBILANT DRAXIMAGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC-99M MERTIATIDE KIT","activeIngredients":"TECHNETIUM TC-99M MERTIATIDE KIT","strength":"5-10MCI","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/216820Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2023","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\\\/2023\\\/216820Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/216820Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-30
        )

)