Documents
Application Sponsors
| ANDA 090547 | MYLAN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | VORICONAZOLE | VORICONAZOLE |
| 002 | TABLET;ORAL | 200MG | 0 | VORICONAZOLE | VORICONAZOLE |
FDA Submissions
| ORIG | 1 | AP | 2010-04-22 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-03-27 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-01-12 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-01-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90547
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VORICONAZOLE","submission":"VORICONAZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VORICONAZOLE","submission":"VORICONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)