ZYDUS PHARMS USA INC FDA Approval ANDA 209829

ANDA 209829

ZYDUS PHARMS USA INC

FDA Drug Application

Application #209829

Documents

Letter2019-05-21

Application Sponsors

ANDA 209829ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2019-04-05STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209829
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFACITINIB CITRATE","activeIngredients":"TOFACITINIB CITRATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209829Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-05
        )

)

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