ZYDUS PHARMS USA INC FDA Approval ANDA 214290

ANDA 214290

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214290

Application Sponsors

ANDA 214290ZYDUS PHARMS USA INC

Marketing Status

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

FDA Submissions

UNKNOWN; ORIG1TA2022-09-14STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214290
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"200MG\/2ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX","strength":"500MG\/2ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-14
        )

)

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