Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | TABLET;ORAL | 250MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
002 | TABLET;ORAL | 500MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
003 | TABLET;ORAL | 750MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
004 | TABLET;ORAL | 1GM | 0 | LEVETIRACETAM | LEVETIRACETAM |
FDA Submissions
| ORIG | 1 | AP | 2009-02-10 | |
LABELING; Labeling | SUPPL | 2 | AP | 2010-10-28 | |
LABELING; Labeling | SUPPL | 6 | AP | 2014-09-18 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2014-09-18 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2014-09-18 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2023-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 2023-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 2023-01-05 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2023-01-05 | STANDARD |
Submissions Property Types
SUPPL | 6 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 7 |
SUPPL | 12 | Null | 15 |
SUPPL | 14 | Null | 7 |
SUPPL | 15 | Null | 7 |
SUPPL | 16 | Null | 7 |
SUPPL | 17 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
PRINSTON INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78106
[companyName] => PRINSTON INC
[docInserts] => ["",""]
[products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)