ANDA 208963

ZYDUS PHARMS

FDA Drug Application

Application #208963

Application Sponsors

ANDA 208963

ZYDUS PHARMS

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	150MG	0	FLUCONAZOLE	FLUCONAZOLE
004	TABLET;ORAL	200MG	0	FLUCONAZOLE	FLUCONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-02-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-07-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-10-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-06-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208963
            [companyName] => ZYDUS PHARMS
            [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":"150MG","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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/16\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/16\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/16\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/16\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-16
        )

)