Documents
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
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
)
)