BRECKENRIDGE PHARMS FDA Approval ANDA 207922

ANDA 207922

BRECKENRIDGE PHARMS

FDA Drug Application

Application #207922

Application Sponsors

ANDA 207922BRECKENRIDGE PHARMS

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

002CAPSULE;ORAL110MG0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE
003CAPSULE;ORAL150MG0DABIGATRAN ETEXILATE MESYLATEDABIGATRAN ETEXILATE MESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2022-03-21STANDARD

Submissions Property Types

ORIG1Null29

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
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.