SANDOZ INC FDA Approval ANDA 202388

ANDA 202388

SANDOZ INC

FDA Drug Application

Application #202388

Application Sponsors

ANDA 202388SANDOZ INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET; ORAL50MG; 500MG0SITAGLIPTIN; METFORMIN HYDROCHLORIDESITAGLIPTIN; METFORMIN HYDROCHLORIDE
002TABLET; ORAL50MG; 1000MG0SITAGLIPTIN; METFORMIN HYDROCHLORIDESITAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2013-07-30

Submissions Property Types

ORIG1Null3

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202388
            [companyName] => SANDOZ 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":"07\/30\/2013","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-07-30
        )

)

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