BIOCON PHARMA FDA Approval ANDA 214182

ANDA 214182

BIOCON PHARMA

FDA Drug Application

Application #214182

Application Sponsors

ANDA 214182BIOCON PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2.5MG0EVEROLIMUSEVEROLIMUS
002TABLET;ORAL5MG0EVEROLIMUSEVEROLIMUS
003TABLET;ORAL7.5MG0EVEROLIMUSEVEROLIMUS
004TABLET;ORAL10MG0EVEROLIMUSEVEROLIMUS

FDA Submissions

UNKNOWN; ORIG1AP2021-02-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

BIOCON PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214182
            [companyName] => BIOCON PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)

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