ANDA 212763

ALVOGEN PINE BROOK

FDA Drug Application

Application #212763

Documents

• Letter: 2021-05-06

Application Sponsors

ANDA 212763

ALVOGEN PINE BROOK

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	UNKNOWN	UNKNOWN	0	IBRUTINIB	IBRUTINIB
002	TABLET;ORAL	280MG	0	IBRUTINIB	IBRUTINIB
003	TABLET;ORAL	420MG	0	IBRUTINIB	IBRUTINIB
004	TABLET;ORAL	560MG	0	IBRUTINIB	IBRUTINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALVOGEN PINE BROOK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212763
            [companyName] => ALVOGEN PINE BROOK
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-09
        )

)