SUN PHARM INDS INC FDA Approval NDA 213092

NDA 213092

SUN PHARM INDS INC

FDA Drug Application

Application #213092

Documents

Letter2022-08-03

Application Sponsors

NDA 213092SUN PHARM INDS INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE; ORAL4MG0LENVATINIBLENVATINIB
002CAPSULE; ORAL10MG0LENVATINIBLENVATINIB

FDA Submissions

UNKNOWN; ORIG1TA2022-03-01STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213092
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENVATINIB","activeIngredients":"LENVATINIB","strength":"4MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LENVATINIB","activeIngredients":"LENVATINIB","strength":"10MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/213092Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-01
        )

)

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