Application Sponsors
| ANDA 200882 | SUN PHARMA GLOBAL | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | EQ 20MG BASE/VIAL | 0 | ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM |
| 002 | INJECTABLE;INTRAVENOUS | EQ 40MG BASE/VIAL | 0 | ESOMEPRAZOLE SODIUM | ESOMEPRAZOLE SODIUM |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-03-18 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-04-14 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-04-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
SUN PHARMA GLOBAL
cder:Array
(
[0] => Array
(
[ApplNo] => 200882
[companyName] => SUN PHARMA GLOBAL
[docInserts] => ["",""]
[products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 20MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/14\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/14\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-04-14
)
)