ANDA 214036

INTAS PHARMS LTD

FDA Drug Application

Application #214036

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 214036

INTAS PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	15MG/6.14MG	0	TRIFLURIDINE; TIPIRACIL	TRIFLURIDINE; TIPIRACIL
002	TABLET;ORAL	20MG/8.19MG	0	TRIFLURIDINE; TIPIRACIL	TRIFLURIDINE; TIPIRACIL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

INTAS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214036
            [companyName] => INTAS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIFLURIDINE; TIPIRACIL","activeIngredients":"TRIFLURIDINE; TIPIRACIL","strength":"15MG\/6.14MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TRIFLURIDINE; TIPIRACIL","activeIngredients":"TRIFLURIDINE; TIPIRACIL","strength":"20MG\/8.19MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-13
        )

)