Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213072
Company: ALTHERA PHARMS
Company: ALTHERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 5MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 10MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 20MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 40MG BASE | TABLET;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
03/23/2021 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213072s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213072Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213072Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/23/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213072s000lbl.pdf |