Application Sponsors
ANDA 209081 | AUROBINDO PHARMA LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | RANOLAZINE | RANOLAZINE |
002 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 0 | RANOLAZINE | RANOLAZINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2017-12-04 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209081
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/04\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-12-04
)
)