NDA 209607

PROGENICS PHARMS INC

FDA Drug Application

Application #209607

Documents

• Label: 2018-07-30
• Letter: 2018-08-03
• Review: 2018-12-11

Application Sponsors

NDA 209607

PROGENICS PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

15mCi/ML

1

AZEDRA

IOBENGUANE I-131

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2018-07-30

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

PROGENICS PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209607
            [companyName] => PROGENICS PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZEDRA","activeIngredients":"IOBENGUANE I-131","strength":"15mCi\/ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/30\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209607s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209607s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209607Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209607Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-24
        )

)