ANDA 204591

TEVA PHARMS USA INC

FDA Drug Application

Application #204591

Application Sponsors

ANDA 204591

TEVA PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	50MG;500MG	0	SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	50MG;1000MG	0	SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	100MG;1000MG	0	SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-09-29

STANDARD

Submissions Property Types

ORIG

1

Null

19

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204591
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE","strength":"50MG;500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE","strength":"50MG;1000MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE","strength":"100MG;1000MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-29
        )

)