Application Sponsors
| ANDA 205566 | GLENMARK PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | 67MG | 0 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE |
| 002 | CAPSULE;ORAL | 134MG | 0 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE |
| 003 | CAPSULE;ORAL | 200MG | 0 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-05-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-06-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 205566
[companyName] => GLENMARK PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-15
)
)