Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;ORAL | 5MG/5ML | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
002 | SOLUTION;ORAL | 100MG/5ML | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-30 | STANDARD |
REMS; REMS | SUPPL | 3 | AP | 2019-01-24 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 210758
[companyName] => SPECGX LLC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/24\/2019","submission":"SUPPL-3","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-01-24
)
)