Application Sponsors
| ANDA 076957 | UNIQUE PHARM LABS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | FLUCONAZOLE | FLUCONAZOLE |
| 002 | TABLET;ORAL | 100MG | 0 | FLUCONAZOLE | FLUCONAZOLE |
| 003 | TABLET;ORAL | 200MG | 0 | FLUCONAZOLE | FLUCONAZOLE |
| 004 | TABLET;ORAL | 150MG | 0 | FLUCONAZOLE | FLUCONAZOLE |
FDA Submissions
| ORIG | 1 | AP | 2005-09-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-01-09 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-02-02 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-07-12 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 15 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 76957
[companyName] => UNIQUE PHARM LABS
[docInserts] => ["",""]
[products] => [{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)