ANDA 214350

LUPIN

FDA Drug Application

Application #214350

Application Sponsors

ANDA 214350

LUPIN

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

001	TABLET;ORAL	20MG	0	DASATINIB	DASATINIB
002	TABLET;ORAL	50MG	0	DASATINIB	DASATINIB
003	TABLET;ORAL	70MG	0	DASATINIB	DASATINIB
004	TABLET;ORAL	80MG	0	DASATINIB	DASATINIB
005	TABLET;ORAL	100MG	0	DASATINIB	DASATINIB
006	TABLET;ORAL	140MG	0	DASATINIB	DASATINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214350
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"70MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DASATINIB","activeIngredients":"DASATINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/22\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-22
        )

)