ANDA 208549

PRINSTON INC

FDA Drug Application

Application #208549

Application Sponsors

ANDA 208549

PRINSTON INC

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	RIVAROXABAN	RIVAROXABAN
002	TABLET;ORAL	15MG	0	RIVAROXABAN	RIVAROXABAN
003	TABLET;ORAL	20MG	0	RIVAROXABAN	RIVAROXABAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-05-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PRINSTON INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208549
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIVAROXABAN","activeIngredients":"RIVAROXABAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIVAROXABAN","activeIngredients":"RIVAROXABAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"RIVAROXABAN","activeIngredients":"RIVAROXABAN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/16\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-16
        )

)