Documents
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
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
)
)