NDA 215841

ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

FDA Drug Application

Application #215841

Documents

• Letter: 2022-03-24
• Review: 2022-06-02
• Label: 2022-06-14

Application Sponsors

NDA 215841

ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

37MCI/VIAL

0

LOCAMETZ KIT

GALLIUM GA 68 GOZETOTIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2022-03-23

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215841
            [companyName] => ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOCAMETZ KIT","activeIngredients":"GALLIUM GA 68 GOZETOTIDE","strength":"37MCI\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215841Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)