Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | TABLET;ORAL | 0.25MG | 0 | RISPERIDONE | RISPERIDONE |
| 002 | TABLET;ORAL | 0.5MG | 0 | RISPERIDONE | RISPERIDONE |
| 003 | TABLET;ORAL | 1MG | 0 | RISPERIDONE | RISPERIDONE |
| 004 | TABLET;ORAL | 2MG | 0 | RISPERIDONE | RISPERIDONE |
| 005 | TABLET;ORAL | 3MG | 0 | RISPERIDONE | RISPERIDONE |
| 006 | TABLET;ORAL | 4MG | 0 | RISPERIDONE | RISPERIDONE |
FDA Submissions
| ORIG | 1 | AP | 2008-10-09 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-04-08 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2011-06-20 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-01-03 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-11-06 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
CELLTRION
cder:Array
(
[0] => Array
(
[ApplNo] => 78871
[companyName] => CELLTRION
[docInserts] => ["",""]
[products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)