CHEMO RESEARCH SL FDA Approval ANDA 213317

ANDA 213317

CHEMO RESEARCH SL

FDA Drug Application

Application #213317

Documents

Letter2021-01-07

Application Sponsors

ANDA 213317CHEMO RESEARCH SL

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL0.02MG;1MG0GEMMILYETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

CHEMO RESEARCH SL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213317
            [companyName] => CHEMO RESEARCH SL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMMILY","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-09
        )

)

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