Application Sponsors
| ANDA 208705 | ALEMBIC PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
| 002 | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-09-19 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ALEMBIC PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208705
[companyName] => ALEMBIC PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/19\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/19\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-19
)
)