GLENMARK PHARMS LTD FDA Approval ANDA 204848

ANDA 204848

GLENMARK PHARMS LTD

FDA Drug Application

Application #204848

Application Sponsors

ANDA 204848GLENMARK PHARMS LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL-283MG;0.03MG0DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN; ORIG1AP2016-03-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204848
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE AND ETHINYL ESTRADIOL","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-25
        )

)

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