NDA 216018

SUN PHARMA GLOBAL

FDA Drug Application

Application #216018

Documents

• Letter: 2022-03-01
• Label: 2022-03-01
• Review: 2022-11-03

Application Sponsors

NDA 216018

SUN PHARMA GLOBAL

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GRANULE;EXTENDED RELEASE	500MG	0	ASPRUZYO SPRINKLE	RANOLAZINE
002	GRANULE;EXTENDED RELEASE	1000MG	0	ASPRUZYO SPRINKLE	RANOLAZINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

40

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
        )

)