Application Sponsors
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | 0 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-07-20 | STANDARD |
Submissions Property Types
CDER Filings
SPIL
cder:Array
(
[0] => Array
(
[ApplNo] => 210593
[companyName] => SPIL
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE MAGNESIUM","activeIngredients":"OMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-20
)
)