ANDA 213654

LUPIN LTD

FDA Drug Application

Application #213654

Application Sponsors

ANDA 213654

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	UNKNOWN	UNKNOWN	0	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	10MG; 1GM	0	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	12.5MG; 1GM	0	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
004	TABLET, EXTENDED RELEASE;ORAL	25MG; 1GM	0	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-01-06

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213654
            [companyName] => LUPIN 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":"01\/06\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-06
        )

)