Documents
Application Sponsors
ANDA 208477 | AUROBINDO PHARMA LTD | |
Marketing Status
Application Products
001 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 0 | LORATADINE | LORATADINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-11 | STANDARD |
EFFICACY; Efficacy | SUPPL | 25 | AP | 2022-12-08 | STANDARD |
Submissions Property Types
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208477
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-04-11
)
)