Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | 0 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE |
002 | INJECTABLE;INJECTION | 400MG/200ML (2MG/ML) | 0 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE |
003 | INJECTABLE;INJECTION | 100MG/50ML (2MG/ML) | 0 | FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | FLUCONAZOLE |
FDA Submissions
| ORIG | 1 | AP | 2010-05-26 | |
LABELING; Labeling | SUPPL | 3 | AP | 2014-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2014-11-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-04-20 | UNKNOWN |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
WOODWARD
cder:Array
(
[0] => Array
(
[ApplNo] => 77909
[companyName] => WOODWARD
[docInserts] => ["",""]
[products] => [{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"400MG\/200ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","activeIngredients":"FLUCONAZOLE","strength":"100MG\/50ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"400MG\/200ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER","submission":"FLUCONAZOLE","actionType":"100MG\/50ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)