Application Sponsors
| ANDA 078602 | SUN PHARM INDS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | 0 | ONDANSETRON | ONDANSETRON |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 8MG | 0 | ONDANSETRON | ONDANSETRON |
FDA Submissions
| ORIG | 1 | AP | 2011-02-24 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2017-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-05-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 78602
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ONDANSETRON","activeIngredients":"ONDANSETRON","strength":"4MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ONDANSETRON","activeIngredients":"ONDANSETRON","strength":"8MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ONDANSETRON","submission":"ONDANSETRON","actionType":"4MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ONDANSETRON","submission":"ONDANSETRON","actionType":"8MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)