ATHEM FDA Approval ANDA 207863

ANDA 207863

ATHEM

FDA Drug Application

Application #207863

Application Sponsors

ANDA 207863ATHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL100MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
002TABLET;ORAL200MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE
003TABLET;ORAL300MG0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207863
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.