Documents
Application Sponsors
| ANDA 204228 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 20MG;1.1GM | 0 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE |
| 002 | CAPSULE;ORAL | 40MG;1.1GM | 0 | OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-07-15 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-02-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204228
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204228Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-24
)
)