ANDA 212365

ANNORA PHARMA

FDA Drug Application

Application #212365

Documents

• Letter: 2021-02-02

Application Sponsors

ANDA 212365

ANNORA PHARMA

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

2021-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ANNORA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212365
            [companyName] => ANNORA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212365Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-28
        )

)