Application Sponsors
| ANDA 203306 | NATCO PHARMA LTD | |
Marketing Status
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | 0 | LANSOPRAZOLE | LANSOPRAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-01-13 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-07-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-07-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203306
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/21\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/21\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-21
)
)