ALKEM LABS LTD FDA Approval ANDA 210440

ANDA 210440

ALKEM LABS LTD

FDA Drug Application

Application #210440

Documents

Letter2018-10-15

Application Sponsors

ANDA 210440ALKEM LABS LTD

Marketing Status

None (Tentative Approval)001
Prescription002

Application Products

001CAPSULE, DELAYED RELEASE;ORAL120MG0DIMETHYL FUMARATEDIMETHYL FUMARATE
002CAPSULE, DELAYED RELEASE;ORAL240MG0DIMETHYL FUMARATEDIMETHYL FUMARATE

FDA Submissions

UNKNOWN; ORIG1TA2018-09-11STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210440
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIMETHYL FUMARATE","activeIngredients":"DIMETHYL FUMARATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210440Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-11
        )

)

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