AMNEAL FDA Approval ANDA 214196

ANDA 214196

AMNEAL

FDA Drug Application

Application #214196

Documents

Letter2021-07-08

Application Sponsors

ANDA 214196AMNEAL

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL25MG0ETRAVIRINEETRAVIRINE
002TABLET;ORAL100MG0ETRAVIRINEETRAVIRINE
003TABLET;ORAL200MG0ETRAVIRINEETRAVIRINE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-14STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214196
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETRAVIRINE","activeIngredients":"ETRAVIRINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-14
        )

)

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