ANDA 202426

APOTEX INC

FDA Drug Application

Application #202426

Application Sponsors

ANDA 202426

APOTEX INC

Marketing Status

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

Application Products

001	TABLET; ORAL	50MG; 500MG	0	SITAGLIPTIN; METFORMIN HYDROCHLORIDE	SITAGLIPTIN; METFORMIN HYDROCHLORIDE
002	TABLET; ORAL	50MG; 1000MG	0	SITAGLIPTIN; METFORMIN HYDROCHLORIDE	SITAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-03-10

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202426
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"50MG; 500MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"50MG; 1000MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-03-10
        )

)