XIROMED FDA Approval ANDA 205229

ANDA 205229

XIROMED

FDA Drug Application

Application #205229

Application Sponsors

ANDA 205229XIROMED

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL100MG0PROGESTERONEPROGESTERONE
002CAPSULE;ORAL200MG0PROGESTERONEPROGESTERONE

FDA Submissions

UNKNOWN; ORIG1AP2017-10-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205229
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROGESTERONE","activeIngredients":"PROGESTERONE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-20
        )

)

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