Application Sponsors
| ANDA 203957 | AJANTA PHARMA LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 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 | 2016-10-14 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2021-11-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203957
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-10-14
)
)