ALEMBIC PHARMS LTD FDA Approval ANDA 214031

ANDA 214031

ALEMBIC PHARMS LTD

FDA Drug Application

Application #214031

Application Sponsors

ANDA 214031ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2.5MG0VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
002TABLET;ORAL5MG0VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
003TABLET;ORAL10MG0VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE
004TABLET;ORAL20MG0VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214031
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-04
        )

)

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