XIROMED FDA Approval ANDA 079221

ANDA 079221

XIROMED

FDA Drug Application

Application #079221

Application Sponsors

ANDA 079221XIROMED

Marketing Status

Prescription001

Application Products

001TABLET;ORAL3MG;0.02MG0LORYNADROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

ORIG1AP2011-03-28
LABELING; LabelingSUPPL4AP2012-09-19STANDARD
LABELING; LabelingSUPPL11AP2020-04-28STANDARD
LABELING; LabelingSUPPL13AP2020-04-28STANDARD
LABELING; LabelingSUPPL14AP2020-04-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null15
SUPPL11Null7
SUPPL13Null7
SUPPL14Null15

TE Codes

001PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79221
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORYNA","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.02MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORYNA","submission":"DROSPIRENONE; ETHINYL ESTRADIOL","actionType":"3MG;0.02MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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