ANDA 212810

ALEMBIC GLOBAL

FDA Drug Application

Application #212810

Application Sponsors

ANDA 212810

ALEMBIC GLOBAL

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-09-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212810
            [companyName] => ALEMBIC GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN","activeIngredients":"MELPHALAN","strength":"50MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/07\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-07
        )

)