BAYSHORE PHARMS LLC FDA Approval ANDA 212263

ANDA 212263

BAYSHORE PHARMS LLC

FDA Drug Application

Application #212263

Application Sponsors

ANDA 212263BAYSHORE PHARMS LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORAL400MG0ETODOLACETODOLAC
002TABLET, EXTENDED RELEASE;ORAL500MG0ETODOLACETODOLAC
003TABLET, EXTENDED RELEASE;ORAL600MG0ETODOLACETODOLAC

FDA Submissions

UNKNOWN; ORIG1AP2020-11-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BAYSHORE PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212263
            [companyName] => BAYSHORE PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-24
        )

)

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