Documents
Application Sponsors
| NDA 205777 | PURDUE PHARMA LP | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 5MG;10MG | 1 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 10MG;20MG | 1 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE |
| 003 | TABLET, EXTENDED RELEASE;ORAL | 20MG;40MG | 1 | TARGINIQ | NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2014-07-23 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2015-06-26 | N/A |
| REMS; REMS | SUPPL | 3 | AP | 2016-04-20 | N/A |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 5 | AP | 2016-09-30 | N/A |
| REMS; REMS | SUPPL | 7 | AP | 2017-05-26 | N/A |
| REMS; REMS | SUPPL | 10 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 11 | AP | 2018-09-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 31 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
CDER Filings
PURDUE PHARMA LP
cder:Array
(
[0] => Array
(
[ApplNo] => 205777
[companyName] => PURDUE PHARMA LP
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/205777s010s011lbl.pdf#page=47"]
[products] => [{"drugName":"TARGINIQ","activeIngredients":"NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"5MG;10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TARGINIQ","activeIngredients":"NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"10MG;20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TARGINIQ","activeIngredients":"NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE","strength":"20MG;40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205777s010s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205777s010s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205777s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205777s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205777lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205777lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205777Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205777Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205777s010s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205777Orig1s010s011ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2018","submission":"SUPPL-10","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205777s010s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205777Orig1s010s011ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205777Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2016","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205777Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/16\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205777s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205777Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2016","submission":"SUPPL-3","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205777Orig1s003ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/26\/2015","submission":"SUPPL-2","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205777Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/19\/2014","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205777Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-18
)
)