ANDA 203770

XIROMED

FDA Drug Application

Application #203770

Application Sponsors

ANDA 203770

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.03MG,0.01MG;0.15MG,N/A

0

JAIMIESS

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203770
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"JAIMIESS","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.01MG;0.15MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-27
        )

)