PAR STERILE PRODUCTS FDA Approval NDA 212156

NDA 212156

PAR STERILE PRODUCTS

FDA Drug Application

Application #212156

Documents

Letter2021-06-17

Application Sponsors

NDA 212156PAR STERILE PRODUCTS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUS50MG0MICAFUNGINMICAFUNGIN SODIUM
002INJECTABLE;INTRAVENOUS100MG0MICAFUNGINMICAFUNGIN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-06-16STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

PAR STERILE PRODUCTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212156
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN SODIUM","strength":"50MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN SODIUM","strength":"100MG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212156Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-16
        )

)

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