Application Sponsors
ANDA 216349 | GRAVITI PHARMS | |
Marketing Status
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-06-24 | STANDARD |
Submissions Property Types
CDER Filings
GRAVITI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 216349
[companyName] => GRAVITI PHARMS
[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":"ESOMEPRAZOLE MAGNESIUM","submission":"ESOMEPRAZOLE MAGNESIUM","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE, DELAYED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)