Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 15MG | 1 | ROXICODONE | OXYCODONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 30MG | 1 | ROXICODONE | OXYCODONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 5MG | 1 | ROXICODONE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-08-31 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2009-05-15 | N/A |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-12-16 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 21011
[companyName] => SPECGX LLC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021011s010lbl.pdf#page=28"]
[products] => [{"drugName":"ROXICODONE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ROXICODONE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ROXICODONE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021011s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021011s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021011s008s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-8","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021011s008s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021011s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021011s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021011s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2009","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021011s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2009","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021011s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021011s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21011lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ROXICODONE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ROXICODONE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ROXICODONE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-07
)
)