Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205777
Company: PURDUE PHARMA LP
Company: PURDUE PHARMA LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | 5MG;10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | 10MG;20MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | 20MG;40MG | 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 |
---|---|---|---|---|---|---|---|
07/23/2014 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205777Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf | |
09/18/2018 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf | |
05/26/2017 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205777Orig1s007ltr.pdf |
09/30/2016 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s005ltr.pdf |
12/16/2016 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s004ltr.pdf | |
04/20/2016 | SUPPL-3 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s003ltr.pdf |
06/26/2015 | SUPPL-2 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205777Orig1s002ltr.pdf |
08/19/2014 | SUPPL-1 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/18/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf | |
09/18/2018 | SUPPL-10 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf | |
12/16/2016 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf | |
12/16/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf | |
07/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf |