Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019304
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIPIDIL | FENOFIBRATE | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TRICOR (MICRONIZED) | FENOFIBRATE | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TRICOR (MICRONIZED) | FENOFIBRATE | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| TRICOR (MICRONIZED) | FENOFIBRATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/24/2000 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19304-S005_Tricor_prntlbl.pdf |