SUNSHINE LAKE FDA Approval ANDA 206524

ANDA 206524

SUNSHINE LAKE

FDA Drug Application

Application #206524

Application Sponsors

ANDA 206524SUNSHINE LAKE

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORALEQ 2.5MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE
002TABLET;ORALEQ 5MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE
003TABLET;ORALEQ 10MG BASE0AMLODIPINE BESYLATEAMLODIPINE BESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2018-05-04STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

SUNSHINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206524
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)

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