IMPAX LABS FDA Approval ANDA 080079

ANDA 080079

IMPAX LABS

FDA Drug Application

Application #080079

Application Sponsors

ANDA 080079IMPAX LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL167MG;167MG;167MG0SULFA-TRIPLE #2TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)

FDA Submissions

ORIG1AP1974-01-23
LABELING; LabelingSUPPL44AP1989-08-04

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80079
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFA-TRIPLE #2","activeIngredients":"TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)","strength":"167MG;167MG;167MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFA-TRIPLE #2","submission":"TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)","actionType":"167MG;167MG;167MG","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.