NDA 215888

MYCOVIA PHARMACEUTICALS INC

FDA Drug Application

Application #215888

Documents

• Letter: 2022-04-27
• Label: 2022-04-28
• Review: 2022-05-11

Application Sponsors

NDA 215888

MYCOVIA PHARMACEUTICALS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE; ORAL

150MG

0

VIVJOA

OTESECONAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-04-26

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MYCOVIA PHARMACEUTICALS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215888
            [companyName] => MYCOVIA PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIVJOA","activeIngredients":"OTESECONAZOLE","strength":"150MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/26\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215888s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/26\/2022","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\\\/2022\\\/215888s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215888Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-04-26
        )

)