Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 5MG/5ML | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-11-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2018-06-22 | UNKNOWN |
REMS; REMS | SUPPL | 3 | AP | 2018-09-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2020-03-20 | UNKNOWN |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 7 | Null | 7 |
TE Codes
CDER Filings
EYWA
cder:Array
(
[0] => Array
(
[ApplNo] => 207511
[companyName] => EYWA
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/20\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2018","submission":"SUPPL-3","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-03-20
)
)