Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 750MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-05-21 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-11-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2021-11-17 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-11-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
PRINSTON INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203468
[companyName] => PRINSTON INC
[docInserts] => ["",""]
[products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-05-21
)
)