INFORLIFE FDA Approval NDA 211844

NDA 211844

INFORLIFE

FDA Drug Application

Application #211844

Documents

Label2021-03-23
Letter2021-03-24

Application Sponsors

NDA 211844INFORLIFE

Marketing Status

Prescription001
Prescription002

Application Products

001UNKNOWNUNKNOWN2MIDAZOLAMMIDAZOLAM
002SOLUTION;INTRAVENOUS100MG/100ML (1MG/ML)1MIDAZOLAM IN 0.9% SODIUM CHLORIDEMIDAZOLAM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-03-22PRIORITY

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

INFORLIFE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211844
            [companyName] => INFORLIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM","activeIngredients":"MIDAZOLAM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211844s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211844s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-03-22
        )

)

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