NDA 213953

MARIUS PHARMACEUTICALS, LLC

FDA Drug Application

Application #213953

Documents

• Letter: 2022-07-28
• Label: 2022-07-28
• Review: 2022-12-21

Application Sponsors

NDA 213953

MARIUS PHARMACEUTICALS, LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE; ORAL	100MG	0	KYZATREX	TESTOSTERONE UNDECANOATE
002	CAPSULE; ORAL	150MG	0	KYZATREX	TESTOSTERONE UNDECANOATE
003	CAPSULE; ORAL	200MG	0	KYZATREX	TESTOSTERONE UNDECANOATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-07-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

MARIUS PHARMACEUTICALS, LLC

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(
    [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
        )

)