ANDA 213601

XIROMED

FDA Drug Application

Application #213601

Application Sponsors

ANDA 213601

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

2%

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213601
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)