BOEHRINGER INGELHEIM FDA Approval NDA 214358

NDA 214358

BOEHRINGER INGELHEIM

FDA Drug Application

Application #214358

Documents

Label2021-06-22
Medication Guide2021-06-22
Letter2021-06-23

Application Sponsors

NDA 214358BOEHRINGER INGELHEIM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001PELLETS;ORAL20MG0PRADAXADABIGATRAN
002PELLETS;ORAL30MG0PRADAXADABIGATRAN
003PELLETS;ORAL40MG0PRADAXADABIGATRAN
004PELLETS;ORAL50MG0PRADAXADABIGATRAN
005PELLETS;ORAL110MG0PRADAXADABIGATRAN
006PELLETS;ORAL150MG0PRADAXADABIGATRAN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-06-21PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

BOEHRINGER INGELHEIM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214358
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/214358s000lbl.pdf#page=14"]
            [products] => [{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"20MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"30MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"40MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"50MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"110MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PRADAXA","activeIngredients":"DABIGATRAN","strength":"150MG","dosageForm":"PELLETS;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214358s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214358s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214358Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-21
        )

)

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