NDA 214358

BOEHRINGER INGELHEIM

FDA Drug Application

Application #214358

Documents

• Label: 2021-06-22
• Medication Guide: 2021-06-22
• Letter: 2021-06-23
• Letter: 2022-03-28
• Review: 2022-04-01
• Label: 2022-04-05
• Medication Guide: 2022-04-05

Application Sponsors

NDA 214358

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	PELLETS;ORAL	20MG	0	PRADAXA	DABIGATRAN
002	PELLETS;ORAL	30MG	0	PRADAXA	DABIGATRAN
003	PELLETS;ORAL	40MG	0	PRADAXA	DABIGATRAN
004	PELLETS;ORAL	50MG	0	PRADAXA	DABIGATRAN
005	PELLETS;ORAL	110MG	0	PRADAXA	DABIGATRAN
006	PELLETS;ORAL	150MG	0	PRADAXA	DABIGATRAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2021-06-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-03-04	STANDARD

Submissions Property Types

ORIG

1

Null

7

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
        )

)