Application Sponsors
| ANDA 206880 | GLAND PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 500MG/100ML (5MG/ML) | 0 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM |
| 002 | INJECTABLE;INTRAVENOUS | 1000MG/100ML (10MG/ML) | 0 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM |
| 003 | INJECTABLE;INTRAVENOUS | 1500MG/100ML (15MG/ML) | 0 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-04-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
| 003 | Prescription | AP |
CDER Filings
GLAND PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 206880
[companyName] => GLAND PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"500MG\/100ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1000MG\/100ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1500MG\/100ML (15MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/20\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/20\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-20
)
)