Application Sponsors
ANDA 207922 | BRECKENRIDGE PHARMS | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
002 | CAPSULE;ORAL | 110MG | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
003 | CAPSULE;ORAL | 150MG | 0 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-03-21 | STANDARD |
Submissions Property Types
CDER Filings
BRECKENRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 207922
[companyName] => BRECKENRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"110MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DABIGATRAN ETEXILATE MESYLATE","activeIngredients":"DABIGATRAN ETEXILATE MESYLATE","strength":"150MG","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
)
)