Application Sponsors
| ANDA 201921 | NATCO PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | 0 | LANSOPRAZOLE | LANSOPRAZOLE |
| 002 | CAPSULE, DELAYED REL PELLETS;ORAL | 30MG | 0 | LANSOPRAZOLE | LANSOPRAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-12-18 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-06-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201921
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/03\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-06-03
)
)