NDA 214621

MYOVANT SCIENCES GMBH

FDA Drug Application

Application #214621

Documents

• Label: 2020-12-18
• Letter: 2020-12-23
• Review: 2021-01-07

Application Sponsors

NDA 214621

MYOVANT SCIENCES GMBH

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

120MG

2

ORGOVYX

RELUGOLIX

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-12-18

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MYOVANT SCIENCES GMBH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214621
            [companyName] => MYOVANT SCIENCES GMBH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORGOVYX","activeIngredients":"RELUGOLIX","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214621s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/18\/2020","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\\\/2020\\\/214621s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/214621Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)