STRIDES PHARMA FDA Approval ANDA 211928

ANDA 211928

STRIDES PHARMA

FDA Drug Application

Application #211928

Application Sponsors

ANDA 211928STRIDES PHARMA

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL250MG0ETHOSUXIMIDEETHOSUXIMIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-19STANDARD
LABELING; LabelingSUPPL2AP2022-08-25STANDARD
LABELING; LabelingSUPPL3AP2022-08-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null7

TE Codes

001PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211928
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHOSUXIMIDE","activeIngredients":"ETHOSUXIMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-19
        )

)

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