NDA 213801

ASTELLAS PHARMA GLOBAL DEV INC

FDA Drug Application

Application #213801

Documents

• Label: 2021-03-29
• Letter: 2021-03-30
• Review: 2022-01-26

Application Sponsors

NDA 213801

ASTELLAS PHARMA GLOBAL DEV INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

8MG/ML

2

MYRBETRIQ

MIRABEGRON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2021-03-25

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

ASTELLAS PHARMA GLOBAL DEV INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213801
            [companyName] => ASTELLAS PHARMA GLOBAL DEV INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYRBETRIQ","activeIngredients":"MIRABEGRON","strength":"8MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/25\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213801s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213801s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213801Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-25
        )

)