MYOVANT SCIENCES FDA Approval NDA 214846

NDA 214846

MYOVANT SCIENCES

FDA Drug Application

Application #214846

Documents

Label2021-05-26
Letter2021-05-27

Application Sponsors

NDA 214846MYOVANT SCIENCES

Marketing Status

Prescription001

Application Products

001TABLET;ORAL40MG;1MG;0.5MG2MYFEMBREERELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2021-05-26STANDARD

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

MYOVANT SCIENCES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214846
            [companyName] => MYOVANT SCIENCES
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYFEMBREE","activeIngredients":"RELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE","strength":"40MG;1MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","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\\\/214846s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214846s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214846Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-26
        )

)

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