TEVA PHARMS USA FDA Approval NDA 212125

NDA 212125

TEVA PHARMS USA

FDA Drug Application

Application #212125

Documents

Letter2020-12-01

Application Sponsors

NDA 212125TEVA PHARMS USA

Marketing Status

None (Tentative Approval)001

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2020-11-25STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212125
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212125Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-25
        )

)

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