GLENMARK PHARMS LTD FDA Approval ANDA 210716

ANDA 210716

GLENMARK PHARMS LTD

FDA Drug Application

Application #210716

Application Sponsors

ANDA 210716GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2.5MG0TADALAFILTADALAFIL
002TABLET;ORAL5MG0TADALAFILTADALAFIL
003TABLET;ORAL10MG0TADALAFILTADALAFIL
004TABLET;ORAL20MG0TADALAFILTADALAFIL

FDA Submissions

UNKNOWN; ORIG1AP2020-12-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB1

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210716
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TADALAFIL","activeIngredients":"TADALAFIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-29
        )

)

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