Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206084
Company: ALTHERA PHARMS
Company: ALTHERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYPQOZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 10MG BASE;10MG | TABLET;ORAL | Prescription | None | No | No |
| LYPQOZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 20MG BASE;10MG | TABLET;ORAL | Prescription | None | No | No |
| LYPQOZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 40MG BASE;10MG | TABLET;ORAL | Prescription | None | No | No |
| LYPQOZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 80MG BASE;10MG | TABLET;ORAL | Prescription | None | No | Yes |
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 | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206084Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/13/2021 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |