Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075868
Company: IMPAX LABS
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 67MG | CAPSULE;ORAL | Discontinued | None | No | No |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 134MG | CAPSULE;ORAL | Discontinued | None | No | No |
| FENOFIBRATE (MICRONIZED) | FENOFIBRATE | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/27/2003 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75868.ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2018 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |