APOTEX INC FDA Approval ANDA 202425

ANDA 202425

APOTEX INC

FDA Drug Application

Application #202425

Application Sponsors

ANDA 202425APOTEX INC

Marketing Status

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

Application Products

001TABLET; ORAL25MG0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE
002TABLET; ORAL50MG0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE
003TABLET; ORAL100MG0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1TA2014-02-18

Submissions Property Types

ORIG1Null19

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202425
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"100MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-18
        )

)

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