Application Sponsors
| ANDA 202882 | HETERO LABS LTD V | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | 0 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM |
| 002 | TABLET, DELAYED RELEASE;ORAL | EQ 40MG BASE | 0 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-09-10 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-06-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 7 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 202882
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/26\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/18\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/18\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-06-26
)
)