Application Sponsors
ANDA 207753 | AUROBINDO PHARMA LTD | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT | 0 | IBUPROFEN | IBUPROFEN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-29 | STANDARD |
Submissions Property Types
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207753
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-06-29
)
)