IMPAX LABS FDA Approval ANDA 080874

ANDA 080874

IMPAX LABS

FDA Drug Application

Application #080874

Application Sponsors

ANDA 080874IMPAX LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 250MG BASE0PIPERAZINE CITRATEPIPERAZINE CITRATE

FDA Submissions

ORIG1AP1973-07-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-02-06
LABELING; LabelingSUPPL4AP1989-05-24

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL4Null0

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80874
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERAZINE CITRATE","activeIngredients":"PIPERAZINE CITRATE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PIPERAZINE CITRATE","submission":"PIPERAZINE CITRATE","actionType":"EQ 250MG 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.