Application Sponsors
| ANDA 077542 | SUN PHARM INDS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | 0 | RISPERIDONE | RISPERIDONE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | 0 | RISPERIDONE | RISPERIDONE |
| 003 | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | 0 | RISPERIDONE | RISPERIDONE |
FDA Submissions
| ORIG | 1 | AP | 2010-08-06 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2012-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-11-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-09-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 77542
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"0.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"1MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RISPERIDONE","activeIngredients":"RISPERIDONE","strength":"2MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"0.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"1MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RISPERIDONE","submission":"RISPERIDONE","actionType":"2MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)