ANDA 212239

ANNORA PHARMA

FDA Drug Application

Application #212239

Application Sponsors

ANDA 212239

ANNORA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

ITRACONAZOLE

ITRACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212239
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)