Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
002 | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | 0 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-30 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2018-07-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 209735
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/23\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-07-23
)
)