EYWA FDA Approval ANDA 214768

ANDA 214768

EYWA

FDA Drug Application

Application #214768

Application Sponsors

ANDA 214768EYWA

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL50MG0TRIAMTERENETRIAMTERENE
002CAPSULE;ORAL100MG0TRIAMTERENETRIAMTERENE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

EYWA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214768
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE","activeIngredients":"TRIAMTERENE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAMTERENE","activeIngredients":"TRIAMTERENE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-06
        )

)

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