Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200153
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/03/2013 | ORIG-1 | Approval | Type 2 New Active Ingredient and Type 4 New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200153Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153_liptruzet_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/200153Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/25/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200153s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200153Orig1s012ltr.pdf | |
| 08/04/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s006ltr.pdf | |
| 09/28/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200153Orig1s005ltr.pdf | |
| 05/16/2014 | SUPPL-3 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200153Orig1s003ltr.pdf | |
| 02/13/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/25/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200153s012lbl.pdf | |
| 09/28/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s005lbl.pdf | |
| 08/04/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200153s006lbl.pdf | |
| 05/16/2014 | SUPPL-3 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200153s003lbl.pdf |
| 05/03/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200153s000lbl.pdf |