ANDA 210457

STRIDES PHARMA

FDA Drug Application

Application #210457

Application Sponsors

ANDA 210457

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210457
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-18
        )

)