XIROMED FDA Approval ANDA 090794

ANDA 090794

XIROMED

FDA Drug Application

Application #090794

Application Sponsors

ANDA 090794XIROMED

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-280.035MG;0.25MG0ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

ORIG1AP2013-01-30
LABELING; LabelingSUPPL2AP2015-08-31STANDARD
LABELING; LabelingSUPPL4AP2015-08-31STANDARD
LABELING; LabelingSUPPL6AP2022-02-03STANDARD
LABELING; LabelingSUPPL11AP2022-04-29STANDARD

Submissions Property Types

ORIG1Null17
SUPPL2Null15
SUPPL4Null15
SUPPL6Null7
SUPPL11Null15

TE Codes

001PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90794
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTARYLLA","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTARYLLA","submission":"ETHINYL ESTRADIOL; NORGESTIMATE","actionType":"0.035MG;0.25MG","submissionClassification":"TABLET;ORAL-28","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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