SUNSHINE LAKE FDA Approval ANDA 213032

ANDA 213032

SUNSHINE LAKE

FDA Drug Application

Application #213032

Application Sponsors

ANDA 213032SUNSHINE LAKE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 25MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE
002TABLET;ORALEQ 50MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE
003TABLET;ORALEQ 100MG BASE0SILDENAFIL CITRATESILDENAFIL CITRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUNSHINE LAKE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213032
            [companyName] => SUNSHINE LAKE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-11
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.