Application Sponsors
ANDA 208045 | AUROBINDO PHARMA LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
None (Tentative Approval) | 005 |
Application Products
001 | TABLET;ORAL | 20MG | 0 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE |
002 | TABLET;ORAL | 40MG | 0 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE |
003 | TABLET;ORAL | 60MG | 0 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE |
004 | TABLET;ORAL | 80MG | 0 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE |
005 | TABLET;ORAL | 120MG | 0 | LURASIDONE HYDROCHLORIDE | LURASIDONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2016-11-18 | STANDARD |
Submissions Property Types
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208045
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LURASIDONE HYDROCHLORIDE","activeIngredients":"LURASIDONE HYDROCHLORIDE","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/18\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-11-18
)
)