ZYDUS PHARMS USA INC FDA Approval ANDA 214263

ANDA 214263

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214263

Documents

Letter2021-07-08

Application Sponsors

ANDA 214263ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001TABLET;ORAL40MG0OSIMERTINIB MESYLATEOSIMERTINIB MESYLATE
002TABLET;ORAL80MG0OSIMERTINIB MESYLATEOSIMERTINIB MESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2021-06-01STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214263
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSIMERTINIB MESYLATE","activeIngredients":"OSIMERTINIB MESYLATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-01
        )

)

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