YAOPHARMA CO LTD FDA Approval ANDA 215552

ANDA 215552

YAOPHARMA CO LTD

FDA Drug Application

Application #215552

Application Sponsors

ANDA 215552YAOPHARMA CO LTD

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2022-10-04STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215552
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"Tofacitinib","activeIngredients":"Tofacitinib","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"Tofacitinib","activeIngredients":"Tofacitinib","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/04\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-04
        )

)

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