ANDA 205078

SUN PHARMA GLOBAL

FDA Drug Application

Application #205078

Application Sponsors

ANDA 205078

SUN PHARMA GLOBAL

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-04-10

STANDARD

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205078
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE","activeIngredients":"METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/10\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-10
        )

)