Application Sponsors
| ANDA 202095 | LOTUS PHARM CO LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 750MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | LEVETIRACETAM | LEVETIRACETAM |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2016-06-06 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-11-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
LOTUS PHARM CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202095
[companyName] => LOTUS PHARM CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/06\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/15\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/15\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-12-15
)
)