ANDA 207922

BRECKENRIDGE PHARMS

FDA Drug Application

Application #207922

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

ORIG

1

Null

29

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
        )

)