STRIDES PHARMA FDA Approval ANDA 204469

ANDA 204469

STRIDES PHARMA

FDA Drug Application

Application #204469

Application Sponsors

ANDA 204469STRIDES PHARMA

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALT0IBUPROFENIBUPROFEN

FDA Submissions

UNKNOWN; ORIG1AP2018-03-28
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2020-04-06

Submissions Property Types

ORIG1Null17
SUPPL3Null15

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204469
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)

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