ALEMBIC PHARMS LTD FDA Approval ANDA 215238

ANDA 215238

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215238

Application Sponsors

ANDA 215238ALEMBIC PHARMS LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL5MG0IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDE
002TABLET;ORAL7.5MG0IVABRADINE HYDROCHLORIDEIVABRADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-04-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215238
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IVABRADINE HYDROCHLORIDE","activeIngredients":"IVABRADINE HYDROCHLORIDE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-19
        )

)

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