Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201890
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;20MG | TABLET;ORAL | Discontinued | None | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;40MG | TABLET;ORAL | Discontinued | None | No | No |
| EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | 10MG;80MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/26/2017 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/30/2024 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 05/30/2024 | SUPPL-11 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 02/23/2021 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 01/29/2020 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 01/29/2020 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |