Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 54MG | 0 | FENOFIBRATE | FENOFIBRATE |
| 002 | TABLET;ORAL | 160MG | 0 | FENOFIBRATE | FENOFIBRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-08-17 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-10-30 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-06-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 15 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
LUPIN LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204019
[companyName] => LUPIN LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/30\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-30
)
)