ANDA 212394

ALEMBIC PHARMS LTD

FDA Drug Application

Application #212394

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 212394

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-07-17

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212394
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","activeIngredients":"EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/17\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-17
        )

)