Application Sponsors
| ANDA 203898 | LANNETT CO INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
Application Products
| 001 | CAPSULE;ORAL | 5MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 002 | CAPSULE;ORAL | 20MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 003 | CAPSULE;ORAL | 100MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 004 | CAPSULE;ORAL | 140MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 005 | CAPSULE;ORAL | 180MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
| 006 | CAPSULE;ORAL | 250MG | 0 | TEMOZOLOMIDE | TEMOZOLOMIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-02-10 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-01-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
CDER Filings
LANNETT CO INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203898
[companyName] => LANNETT CO INC
[docInserts] => ["",""]
[products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/10\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-02-10
)
)