Application Sponsors
| ANDA 210606 | GRAVITI PHARMS | |
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 | 2018-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-05-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-06-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
GRAVITI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 210606
[companyName] => GRAVITI PHARMS
[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\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-23
)
)