NDA 214793

PROGENICS PHARMS INC

FDA Drug Application

Application #214793

Documents

• Label: 2021-05-27
• Letter: 2021-05-27
• Review: 2021-06-09

Application Sponsors

NDA 214793

PROGENICS PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2960MBQ/ML(1MCI/ML,80MCI/ML)

0

PYLARIFY

PIFLUFOLASTAT F 18

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-05-26

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

PROGENICS PHARMS INC

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(
    [0] => Array
        (
            [ApplNo] => 214793
            [companyName] => PROGENICS PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PYLARIFY","activeIngredients":"PIFLUFOLASTAT F 18","strength":"2960MBQ\/ML(1MCI\/ML,80MCI\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/26\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214793s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214793s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214793Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-26
        )

)