GLAXOSMITHKLINE FDA Approval ANDA 062736

ANDA 062736

GLAXOSMITHKLINE

FDA Drug Application

Application #062736

Application Sponsors

ANDA 062736GLAXOSMITHKLINE

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0BACTOCILLOXACILLIN SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**0BACTOCILLOXACILLIN SODIUM

FDA Submissions

ORIG1AP1986-12-19
LABELING; LabelingSUPPL5AP1994-02-02

CDER Filings

GLAXOSMITHKLINE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62736
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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