Application Sponsors
| ANDA 200794 | SUN PHARM INDS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 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
| N/A; Not Applicable | ORIG | 1 | AP | 2012-05-02 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-01-02 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-01-02 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-04-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 200794
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 20MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/02\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/08\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/02\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/02\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/31\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/31\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-04-08
)
)