Application Sponsors
Marketing Status
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | 20MG | 0 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-11-08 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-11-30 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2022-09-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 7 |
TE Codes
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 202376
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"RABEPRAZOLE SODIUM","activeIngredients":"RABEPRAZOLE SODIUM","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/08\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/30\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-30
)
)