ANDA 212366

ALKEM LABS LTD

FDA Drug Application

Application #212366

Documents

• Letter: 2022-09-08

Application Sponsors

ANDA 212366

ALKEM LABS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	10MG/5MG	0	EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN
002	TABLET;ORAL	25MG/5MG	0	EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212366
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN; LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN;LINAGLIPTIN","strength":"10MG\/5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EMPAGLIFLOZIN; LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN;LINAGLIPTIN","strength":"25MG\/5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-09
        )

)