ANDA 210364

MYLAN

FDA Drug Application

Application #210364

Application Sponsors

ANDA 210364

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

ECONAZOLE NITRATE

ECONAZOLE NITRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-06-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210364
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ECONAZOLE NITRATE","activeIngredients":"ECONAZOLE NITRATE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/08\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-08
        )

)