CADILA FDA Approval ANDA 215680

ANDA 215680

CADILA

FDA Drug Application

Application #215680

Application Sponsors

ANDA 215680CADILA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0BISOPROLOL FUMARATEBISOPROLOL FUMARATE
002TABLET;ORAL10MG0BISOPROLOL FUMARATEBISOPROLOL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215680
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BISOPROLOL FUMARATE","activeIngredients":"BISOPROLOL FUMARATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE","activeIngredients":"BISOPROLOL FUMARATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-25
        )

)

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