MSN LABORATORIES PRIVATE LTD FDA Approval ANDA 213879

ANDA 213879

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #213879

Application Sponsors

ANDA 213879MSN LABORATORIES PRIVATE LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001CAPSULE;ORALEQ 75MG BASE0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE
002CAPSULE;ORALEQ 110MG BASE0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE
003CAPSULE;ORALEQ 150MG BASE0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2022-03-21STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN LABORATORIES PRIVATE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213879
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 110MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-21
        )

)

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