ANDA 213845

SUNSHINE LAKE

FDA Drug Application

Application #213845

Documents

• Letter: 2021-08-16

Application Sponsors

ANDA 213845

SUNSHINE LAKE

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

25MG

0

TENOFOVIR ALAFENAMIDE

TENOFOVIR ALAFENAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SUNSHINE LAKE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213845
            [companyName] => SUNSHINE LAKE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR ALAFENAMIDE","activeIngredients":"TENOFOVIR ALAFENAMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-08
        )

)