GLAXOSMITHKLINE FDA Approval ANDA 062273

ANDA 062273

GLAXOSMITHKLINE

FDA Drug Application

Application #062273

Application Sponsors

ANDA 062273GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORALEQ 250MG BASE0BEEPEN-VKPENICILLIN V POTASSIUM
002TABLET;ORALEQ 500MG BASE0BEEPEN-VKPENICILLIN V POTASSIUM

FDA Submissions

ORIG1AP1980-08-12
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1989-02-06
LABELING; LabelingSUPPL5AP1996-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-04-20

Submissions Property Types

ORIG1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62273
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BEEPEN-VK","activeIngredients":"PENICILLIN V POTASSIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BEEPEN-VK","submission":"PENICILLIN V POTASSIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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