BIOCON PHARMA FDA Approval ANDA 214630

ANDA 214630

BIOCON PHARMA

FDA Drug Application

Application #214630

Application Sponsors

ANDA 214630BIOCON PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, DELAYED RELEASE;ORALEQ 180MG BASE0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID
002TABLET, DELAYED RELEASE;ORALEQ 360MG BASE0MYCOPHENOLIC ACIDMYCOPHENOLIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2021-11-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BIOCON PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214630
            [companyName] => BIOCON PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"EQ 180MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MYCOPHENOLIC ACID","activeIngredients":"MYCOPHENOLIC ACID","strength":"EQ 360MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-29
        )

)

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