ANDA 215238

ALEMBIC PHARMS LTD

FDA Drug Application

Application #215238

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 215238

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORAL	5MG	0	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE
002	TABLET;ORAL	7.5MG	0	IVABRADINE HYDROCHLORIDE	IVABRADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)