XIROMED FDA Approval ANDA 202789

ANDA 202789

XIROMED

FDA Drug Application

Application #202789

Application Sponsors

ANDA 202789XIROMED

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.15MG;0.03MG0ISIBLOOMDESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2015-08-12
LABELING; LabelingSUPPL3AP2017-08-09STANDARD
LABELING; LabelingSUPPL7AP2022-04-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL7Null7

TE Codes

001PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202789
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISIBLOOM","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/26\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)

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