ANDA 208535

ZYDUS PHARMS USA INC

FDA Drug Application

Application #208535

Application Sponsors

ANDA 208535

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

50MG/500MG;50MG/1000MG

0

METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE

METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-07-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208535
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE","activeIngredients":"METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE","strength":"50MG\/500MG;50MG\/1000MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/03\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-03
        )

)