Application Sponsors
| ANDA 204092 | MAYNE PHARMA INC | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 100MG/5ML | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-06-05 | |
| REMS; REMS | SUPPL | 3 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-02-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
MAYNE PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204092
[companyName] => MAYNE PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/05\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","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] => 2020-02-12
)
)