MARIUS PHARMACEUTICALS, LLC FDA Approval NDA 213953

NDA 213953

MARIUS PHARMACEUTICALS, LLC

FDA Drug Application

Application #213953

Documents

Letter2022-07-28
Label2022-07-28

Application Sponsors

NDA 213953MARIUS PHARMACEUTICALS, LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE; ORAL100MG0KYZATREXTESTOSTERONE UNDECANOATE
002CAPSULE; ORAL150MG0KYZATREXTESTOSTERONE UNDECANOATE
003CAPSULE; ORAL200MG0KYZATREXTESTOSTERONE UNDECANOATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-07-27STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

MARIUS PHARMACEUTICALS, LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213953
            [companyName] => MARIUS PHARMACEUTICALS, LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KYZATREX","activeIngredients":"TESTOSTERONE UNDECANOATE","strength":"100MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"KYZATREX","activeIngredients":"TESTOSTERONE UNDECANOATE","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"KYZATREX","activeIngredients":"TESTOSTERONE UNDECANOATE","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213953s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/213953s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213953Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-07-27
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.