Application Sponsors
| ANDA 200821 | MACLEODS PHARMS LTD | |
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 | 2012-02-16 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2013-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-04-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2016-09-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-09-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 19 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 200821
[companyName] => MACLEODS PHARMS 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":"02\/16\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/09\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/12\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/12\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-13
)
)