ANDA 216261

ALEMBIC PHARMS LTD

FDA Drug Application

Application #216261

Application Sponsors

ANDA 216261

ALEMBIC PHARMS LTD

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

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

2022-06-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216261
            [companyName] => ALEMBIC PHARMS LTD
            [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":"06\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)