ANDA 212364

ANNORA PHARMA

FDA Drug Application

Application #212364

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 212364

ANNORA PHARMA

Marketing Status

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

Application Products

001	UNKNOWN	UNKNOWN	0	EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN
002	TABLET;ORAL	25MG; 5MG	0	EMPAGLIFLOZIN; LINAGLIPTIN	EMPAGLIFLOZIN;LINAGLIPTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-03-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212364
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN; LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN;LINAGLIPTIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-30
        )

)