SANDOZ INC FDA Approval ANDA 210297

ANDA 210297

SANDOZ INC

FDA Drug Application

Application #210297

Documents

Letter2021-01-07

Application Sponsors

ANDA 210297SANDOZ INC

Marketing Status

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

Application Products

001TABLET; ORAL100MG0CANAGLIFLOZINCANAGLIFLOZIN

FDA Submissions

UNKNOWN; ORIG1TA2020-11-20STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210297
            [companyName] => SANDOZ INC
            [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":"11\/20\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210297orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-20
        )

)

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