Application Sponsors
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-10-16 | STANDARD |
Submissions Property Types
CDER Filings
MYLAN
cder:Array
(
[0] => Array
(
[ApplNo] => 212376
[companyName] => MYLAN
[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\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-10-16
)
)