Application Sponsors
| ANDA 200475 | MYLAN PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 750MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 0 | LEVETIRACETAM | LEVETIRACETAM |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2011-12-19 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-01-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200475
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/19\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/18\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2014-03-18
)
)