Application Sponsors
| ANDA 091313 | MAYNE PHARMA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 15MG | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 30MG | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 10MG | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
| 005 | TABLET;ORAL | 20MG | 0 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-02-18 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-06-01 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2018-09-18 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
MAYNE PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91313
[companyName] => MAYNE PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)