ANDA 206309 | RISING |
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
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 |
UNKNOWN; | ORIG | 1 | AP | 2016-04-27 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-01-27 | STANDARD |
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
cder:Array ( [0] => Array ( [ApplNo] => 206309 [companyName] => RISING [docInserts] => ["",""] [products] => [{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"180MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TEMOZOLOMIDE","activeIngredients":"TEMOZOLOMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}] [labels] => [originalApprovals] => [{"actionDate":"04\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}] [supplements] => [actionDate] => 2016-04-27 ) )