Application Sponsors
| ANDA 205545 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | 20MG/PACKET;1.68GM/PACKET | 0 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE |
| 002 | FOR SUSPENSION;ORAL | 40MG/PACKET;1.68GM/PACKET | 0 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-04-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205545
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG\/PACKET;1.68GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG\/PACKET;1.68GM\/PACKET","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/06\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-06
)
)