ANDA 202365

WATSON LABS INC

FDA Drug Application

Application #202365

Application Sponsors

ANDA 202365

WATSON LABS INC

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-10-30

Submissions Property Types

ORIG

1

Null

1

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202365
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","strength":"50MG;500MG","dosageForm":"TABLET;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;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-10-30
        )

)