SUN PHARMA ADVANCED RESEARCH COMPANY, LTD. FDA Approval NDA 215910

NDA 215910

SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.

FDA Drug Application

Application #215910

Documents

Letter2022-11-18

Application Sponsors

NDA 215910SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.

Marketing Status

Prescription001

Application Products

001SOLUTION; INJECTION100MG0SEZABYPHENOBARBITAL

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-11-17PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215910
            [companyName] => SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.
            [docInserts] => ["",""]
            [products] => [{"drugName":"SEZABY","activeIngredients":"PHENOBARBITAL","strength":"100MG","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215910Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-17
        )

)

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