Application Sponsors
ANDA 201890 | ANI PHARMS INC | |
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
N/A; Not Applicable | ORIG | 1 | AP | 2017-04-26 | |
LABELING; Labeling | SUPPL | 5 | AP | 2019-04-02 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2020-01-29 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2020-01-29 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2021-02-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 5 | Null | 15 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201890
[companyName] => ANI PHARMS INC
[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":"04\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/29\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/29\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-29
)
)