ANDA 212198

ZYDUS PHARMS USA INC

FDA Drug Application

Application #212198

Documents

• Letter: 2020-05-19

Application Sponsors

ANDA 212198

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	UNKNOWN	UNKNOWN	0	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	5MG; 1G	0	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	12.5MG; 500MG	0	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
004	TABLET;ORAL	12.5MG; 1GM	0	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212198
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","activeIngredients":"EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/30\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212198Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-30
        )

)