Application Sponsors
| ANDA 090516 | MYLAN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | NABUMETONE | NABUMETONE |
| 002 | TABLET;ORAL | 750MG | 0 | NABUMETONE | NABUMETONE |
FDA Submissions
| ORIG | 1 | AP | 2010-07-12 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90516
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NABUMETONE","submission":"NABUMETONE","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)