Application Sponsors
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 | 2016-07-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
XIROMED
cder:Array
(
[0] => Array
(
[ApplNo] => 203203
[companyName] => XIROMED
[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":"07\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/20\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-20
)
)