ANDA 205329

XIROMED

FDA Drug Application

Application #205329

Application Sponsors

ANDA 205329

XIROMED

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

1.5MG

0

LEVONORGESTREL

LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205329
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL","activeIngredients":"LEVONORGESTREL","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-18
        )

)