NDA 210923

SHIONOGI INC

FDA Drug Application

Application #210923

Documents

• Label: 2018-07-31
• Letter: 2018-08-02
• Review: 2018-08-22

Application Sponsors

NDA 210923

SHIONOGI INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG

1

MULPLETA

LUSUTROMBOPAG

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2018-07-31

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SHIONOGI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210923
            [companyName] => SHIONOGI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MULPLETA","activeIngredients":"LUSUTROMBOPAG","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210923s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/31\/2018","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\\\/2018\\\/210923s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210923Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210923Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-07-31
        )

)