Application Sponsors
| ANDA 091417 | SUN PHARM INDS LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | RILUZOLE | RILUZOLE |
FDA Submissions
| ORIG | 1 | AP | 2013-06-18 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-09-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 11 | Null | 15 |
TE Codes
CDER Filings
SUN PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 91417
[companyName] => SUN PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RILUZOLE","activeIngredients":"RILUZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"RILUZOLE","submission":"RILUZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)