LOTUS PHARM CO LTD FDA Approval ANDA 210480

ANDA 210480

LOTUS PHARM CO LTD

FDA Drug Application

Application #210480

Application Sponsors

ANDA 210480LOTUS PHARM CO LTD

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; ORIG1TA2020-09-24STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

LOTUS PHARM CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210480
            [companyName] => LOTUS PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-24
        )

)

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