UNICHEM LABS LTD FDA Approval ANDA 214693

ANDA 214693

UNICHEM LABS LTD

FDA Drug Application

Application #214693

Application Sponsors

ANDA 214693UNICHEM LABS LTD

Marketing Status

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

Application Products

001TABLET;ORALEQ 25MG BASE0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE
002TABLET;ORALEQ 50MG BASE0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE
003TABLET;ORALEQ 100MG BASE0SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1TA2021-07-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

UNICHEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214693
            [companyName] => UNICHEM 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":"07\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)

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