ANDA 213064

ZYDUS PHARMS USA INC

FDA Drug Application

Application #213064

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 213064

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	15MG	0	EDOXABAN	EDOXABAN
002	TABLET;ORAL	30MG	0	EDOXABAN	EDOXABAN
003	TABLET;ORAL	60MG	0	EDOXABAN	EDOXABAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213064
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-16
        )

)