ANDA 212138

ZYDUS PHARMS USA

FDA Drug Application

Application #212138

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 212138

ZYDUS PHARMS USA

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-04-09

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212138
            [companyName] => ZYDUS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212138Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-09
        )

)