METHOD FDA Approval ANDA 212727

ANDA 212727

METHOD

FDA Drug Application

Application #212727

Application Sponsors

ANDA 212727METHOD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 1MG BASE0DOXAZOSIN MESYLATEDOXAZOSIN MESYLATE
002TABLET;ORALEQ 2MG BASE0DOXAZOSIN MESYLATEDOXAZOSIN MESYLATE
003TABLET;ORALEQ 4MG BASE0DOXAZOSIN MESYLATEDOXAZOSIN MESYLATE
004TABLET;ORALEQ 8MG BASE0DOXAZOSIN MESYLATEDOXAZOSIN MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

METHOD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212727
            [companyName] => METHOD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXAZOSIN MESYLATE","activeIngredients":"DOXAZOSIN MESYLATE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-15
        )

)

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