Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204031
Company: MALLINCKRODT INC
Company: MALLINCKRODT INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XARTEMIS XR | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/11/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204031s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204031Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204031Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204031Orig1s004s005ltr.pdf | |
| 09/18/2018 | SUPPL-4 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204031Orig1s004s005ltr.pdf | |
| 12/16/2016 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204031Orig1s003ltr.pdf | |
| 01/26/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204031s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204031Orig2s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf | |
| 09/18/2018 | SUPPL-4 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204031s004s005lbl.pdf | |
| 12/16/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf | |
| 12/16/2016 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204031s003lbl.pdf | |
| 03/12/2015 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204031s001lbl.pdf | |
| 03/11/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204031s000lbl.pdf |