Application Sponsors
| ANDA 209222 | ALKEM LABS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 10MG;10MG | 0 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN |
| 002 | TABLET;ORAL | 10MG;20MG | 0 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN |
| 003 | TABLET;ORAL | 10MG;40MG | 0 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN |
| 004 | TABLET;ORAL | 10MG;80MG | 0 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-09-26 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-12-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 12 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ALKEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209222
[companyName] => ALKEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EZETIMIBE AND SIMVASTATIN","activeIngredients":"EZETIMIBE; SIMVASTATIN","strength":"10MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/29\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/16\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-29
)
)