ORGANON USA INC FDA Approval ANDA 080997

ANDA 080997

ORGANON USA INC

FDA Drug Application

Application #080997

Application Sponsors

ANDA 080997ORGANON USA INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION20MG/ML0SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDE

FDA Submissions

ORIG1AP1972-09-20
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1991-04-02
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1994-03-07
LABELING; LabelingSUPPL10AP1996-04-17
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-06-09

Submissions Property Types

ORIG1Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0

CDER Filings

ORGANON USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80997
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUCCINYLCHOLINE CHLORIDE","activeIngredients":"SUCCINYLCHOLINE CHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUCCINYLCHOLINE CHLORIDE","submission":"SUCCINYLCHOLINE CHLORIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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