NATCO PHARMA LTD FDA Approval ANDA 201452

ANDA 201452

NATCO PHARMA LTD

FDA Drug Application

Application #201452

Documents

Letter2021-06-03

Application Sponsors

ANDA 201452NATCO PHARMA LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL5MG0LENALIDOMIDELENALIDOMIDE
002CAPSULE;ORAL10MG0LENALIDOMIDELENALIDOMIDE
003CAPSULE;ORAL15MG0LENALIDOMIDELENALIDOMIDE
004CAPSULE;ORAL25MG0LENALIDOMIDELENALIDOMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-05-21
UNKNOWN; ORIG2TA2021-05-25UNKNOWN

Submissions Property Types

ORIG1Null15
ORIG2Null19

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

NATCO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201452
            [companyName] => NATCO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LENALIDOMIDE","activeIngredients":"LENALIDOMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/201452Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.