Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208379
Company: MEDICURE
Company: MEDICURE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 1MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 2MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| ZYPITAMAG | PITAVASTATIN MAGNESIUM | EQ 4MG BASE | TABLET;ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/14/2017 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208379s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208379Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208379_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208379Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/31/2024 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208379s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208379Orig1s005ltr.pdf | |
| 09/25/2020 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208379s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208379Orig1s004ltr.pdf | |
| 02/07/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208379Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/31/2024 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208379s005lbl.pdf | |
| 09/25/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208379s004lbl.pdf | |
| 02/07/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208379s003lbl.pdf | |
| 07/14/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208379s000lbl.pdf |