ANDA 209944

SUNSHINE LAKE

FDA Drug Application

Application #209944

Documents

• Letter: 2019-03-13

Application Sponsors

ANDA 209944

SUNSHINE LAKE

Marketing Status

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

Application Products

001	TABLET;ORAL	2.GMG	0	APIXABAN	APIXABAN
002	TABLET;ORAL	5MG	0	APIXABAN	APIXABAN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-09-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUNSHINE LAKE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209944
            [companyName] => SUNSHINE LAKE
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.GMG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209944Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-10
        )

)