SEDOR PHARMS LLC FDA Approval NDA 210864

NDA 210864

SEDOR PHARMS LLC

FDA Drug Application

Application #210864

Documents

Label2020-11-09
Letter2020-11-09

Application Sponsors

NDA 210864SEDOR PHARMS LLC

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUSEQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)1SESQUIENTFOSPHENYTOIN SODIUM
002SOLUTION;INTRAVENOUSEQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)1SESQUIENTFOSPHENYTOIN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-11-05STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

SEDOR PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210864
            [companyName] => SEDOR PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SESQUIENT","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 100MG PHENYTOIN NA\/2ML (EQ 50MG PHENYTOIN NA\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SESQUIENT","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 500MG PHENYTOIN NA\/10ML (EQ 50MG PHENYTOIN NA\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/05\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210864s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/05\/2020","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\\\/2020\\\/210864s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210864Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-05
        )

)

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