BAXTER HLTHCARE CORP FDA Approval ANDA 074768

ANDA 074768

BAXTER HLTHCARE CORP

FDA Drug Application

Application #074768

Application Sponsors

ANDA 074768BAXTER HLTHCARE CORP

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10MG/ML0ATRACURIUM BESYLATE PRESERVATIVE FREEATRACURIUM BESYLATE

FDA Submissions

ORIG1AP1997-01-23
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-11-22
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-11-22
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-11-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-02-17
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-02-17

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74768
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATRACURIUM BESYLATE PRESERVATIVE FREE","activeIngredients":"ATRACURIUM BESYLATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATRACURIUM BESYLATE PRESERVATIVE FREE","submission":"ATRACURIUM BESYLATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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