Application Sponsors
ANDA 209339 | AUROBINDO PHARMA LTD | |
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-10-16 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-01-15 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-01-15 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 6 | Null | 15 |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209339
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/15\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/15\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-15
)
)