INTAS PHARMS USA FDA Approval ANDA 214054

ANDA 214054

INTAS PHARMS USA

FDA Drug Application

Application #214054

Application Sponsors

ANDA 214054INTAS PHARMS USA

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2022-03-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

INTAS PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214054
            [companyName] => INTAS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-02
        )

)

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