ALKEM LABS LTD FDA Approval ANDA 215155

ANDA 215155

ALKEM LABS LTD

FDA Drug Application

Application #215155

Application Sponsors

ANDA 215155ALKEM LABS LTD

Marketing Status

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

Application Products

002TABLET;ORALEQ 50MG BASE0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE
003TABLET;ORALEQ 100MG BASE0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1TA2022-04-08STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215155
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-08
        )

)

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