SUNSHINE LAKE FDA Approval ANDA 213845

ANDA 213845

SUNSHINE LAKE

FDA Drug Application

Application #213845

Application Sponsors

ANDA 213845SUNSHINE LAKE

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL25MG0TENOFOVIR ALAFENAMIDETENOFOVIR ALAFENAMIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-07-08STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

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