Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | 0 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE |
002 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | 0 | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE |
FDA Submissions
| ORIG | 1 | AP | 2010-05-26 | |
LABELING; Labeling | SUPPL | 2 | AP | 2014-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2014-11-10 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 42 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
CDER Filings
WOODWARD
cder:Array
(
[0] => Array
(
[ApplNo] => 77988
[companyName] => WOODWARD
[docInserts] => ["",""]
[products] => [{"drugName":"FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"400MG\/200ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"400MG\/200ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)