NDA 211728

UROGEN PHARMA LTD

FDA Drug Application

Application #211728

Documents

• Label: 2020-04-15
• Letter: 2020-04-16
• Review: 2020-06-11
• Label: 2021-01-15
• Letter: 2021-01-19

Application Sponsors

NDA 211728

UROGEN PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;PYELOCALYCEAL

2

JELMYTO

MITOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-04-15

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

UROGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211728
            [companyName] => UROGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"JELMYTO","activeIngredients":"MITOMYCIN","strength":"40MG\/VIAL","dosageForm":"POWDER;PYELOCALYCEAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/15\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211728s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/15\/2020","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\\\/2020\\\/211728s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211728Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/211728Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-15
        )

)