SUN PHARMA GLOBAL FDA Approval NDA 216018

NDA 216018

SUN PHARMA GLOBAL

FDA Drug Application

Application #216018

Documents

Letter2022-03-01
Label2022-03-01

Application Sponsors

NDA 216018SUN PHARMA GLOBAL

Marketing Status

Prescription001
Prescription002

Application Products

001GRANULE;EXTENDED RELEASE500MG0ASPRUZYO SPRINKLERANOLAZINE
002GRANULE;EXTENDED RELEASE1000MG0ASPRUZYO SPRINKLERANOLAZINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-02-28STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

SUN PHARMA GLOBAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216018
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASPRUZYO SPRINKLE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"GRANULE;EXTENDED RELEASE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ASPRUZYO SPRINKLE","activeIngredients":"RANOLAZINE","strength":"1000MG","dosageForm":"GRANULE;EXTENDED RELEASE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216018s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216018s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216018Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)

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