TEVA PHARMS USA FDA Approval ANDA 210451

ANDA 210451

TEVA PHARMS USA

FDA Drug Application

Application #210451

Application Sponsors

ANDA 210451TEVA PHARMS USA

Marketing Status

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

Application Products

002TABLET; ORAL300mg0CANAGLIFLOZINCANAGLIFLOZIN

FDA Submissions

UNKNOWN; ORIG1TA2022-06-14STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210451
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANAGLIFLOZIN","activeIngredients":"CANAGLIFLOZIN","strength":"100mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"CANAGLIFLOZIN","activeIngredients":"CANAGLIFLOZIN","strength":"300mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-14
        )

)

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