ANDA 200265

SANDOZ INC

FDA Drug Application

Application #200265

Application Sponsors

ANDA 200265

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2011-12-12
LABELING; Labeling	SUPPL	8	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-10-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-07-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-06-13	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-12-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200265
            [companyName] => SANDOZ INC
            [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":"12\/12\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-09
        )

)