Application Sponsors
| ANDA 204661 | TEVA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | 0 | OMEPRAZOLE | OMEPRAZOLE |
| 002 | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | 0 | OMEPRAZOLE | OMEPRAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-06-13 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 204661
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"40MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/07\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-06-07
)
)