Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | CAPSULE;ORAL | 100MG | 0 | LIPIDIL | FENOFIBRATE |
| 002 | CAPSULE;ORAL | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRICOR (MICRONIZED) | FENOFIBRATE |
| 003 | CAPSULE;ORAL | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRICOR (MICRONIZED) | FENOFIBRATE |
| 004 | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | TRICOR (MICRONIZED) | FENOFIBRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-12-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-06-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2000-04-24 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-03-19 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
CDER Filings
Accessdata Error
cder:Array
(
[0] => Array
(
[ApplNo] => 19304
[companyName] => Accessdata Error
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)