ANDA 212382

ALKEM LABS LTD

FDA Drug Application

Application #212382

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 212382

ALKEM LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG	0	EMPAGLIFLOZIN	EMPAGLIFLOZIN
002	TABLET;ORAL	25MG	0	EMPAGLIFLOZIN	EMPAGLIFLOZIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-09-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212382
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-28
        )

)