Application Sponsors
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 | 2018-06-26 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2021-06-03 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 210782
[companyName] => TORRENT
[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":"06\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/15\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-15
)
)