Application 021203
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58189 | SUPPL | 2019-06-07 |
| 58138 | SUPPL | 2019-03-29 |
| 56494 | SUPPL | 2018-11-16 |
| 56387 | SUPPL | 2018-11-08 |
| 54294 | SUPPL | 2018-05-22 |
| 54274 | SUPPL | 2018-05-21 |
| 47008 | SUPPL | 2017-01-30 |
| 46975 | SUPPL | 2017-01-25 |
| 14629 | SUPPL | 2014-12-10 |
| 27053 | SUPPL | 2014-12-09 |
| 42019 | ORIG | 2005-04-15 |
| 36337 | ORIG | 2001-09-05 |
| 27052 | ORIG | 2001-09-05 |