CADILA FDA Approval ANDA 206747

ANDA 206747

CADILA

FDA Drug Application

Application #206747

Application Sponsors

ANDA 206747CADILA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL50MG0VORICONAZOLEVORICONAZOLE
002TABLET;ORAL200MG0VORICONAZOLEVORICONAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-24STANDARD
LABELING; LabelingSUPPL2AP2019-07-09STANDARD
LABELING; LabelingSUPPL3AP2019-07-09STANDARD
LABELING; LabelingSUPPL4AP2019-07-09STANDARD
LABELING; LabelingSUPPL5AP2021-03-15STANDARD
LABELING; LabelingSUPPL7AP2021-03-15STANDARD
LABELING; LabelingSUPPL8AP2021-03-15STANDARD
LABELING; LabelingSUPPL9AP2022-06-13STANDARD
LABELING; LabelingSUPPL10AP2022-06-13STANDARD
LABELING; LabelingSUPPL12AP2022-06-13STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null7
SUPPL4Null15
SUPPL5Null7
SUPPL7Null7
SUPPL8Null7
SUPPL9Null7
SUPPL10Null15
SUPPL12Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206747
            [companyName] => CADILA
            [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":"05\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/13\/2022","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/13\/2022","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/13\/2022","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/15\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/15\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/15\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2022-06-13
        )

)

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