Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207564
Company: NOVAST LABS
Company: NOVAST 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 |
|---|---|---|---|---|---|---|---|
| 04/19/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |