ZYDUS PHARMS USA INC FDA Approval ANDA 210154

ANDA 210154

ZYDUS PHARMS USA INC

FDA Drug Application

Application #210154

Application Sponsors

ANDA 210154ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

001CAPSULE;ORAL2.5MG0LENALIDOMIDELENALIDOMIDE
002CAPSULE;ORAL5MG0LENALIDOMIDELENALIDOMIDE
003CAPSULE;ORAL10MG0LENALIDOMIDELENALIDOMIDE
004CAPSULE;ORAL15MG0LENALIDOMIDELENALIDOMIDE
005CAPSULE;ORAL20MG0LENALIDOMIDELENALIDOMIDE
006CAPSULE;ORAL25MG0LENALIDOMIDELENALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-08-16STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210154
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-16
        )

)

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