ANDA 206747

CADILA

FDA Drug Application

Application #206747

Application Sponsors

ANDA 206747

CADILA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	0	VORICONAZOLE	VORICONAZOLE
002	TABLET;ORAL	200MG	0	VORICONAZOLE	VORICONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-03-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-03-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-03-15	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-06-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)