ROERIG FDA Approval NDA 050306

NDA 050306

ROERIG

FDA Drug Application

Application #050306

Application Sponsors

NDA 050306ROERIG

Marketing Status

Discontinued001
Discontinued002
Discontinued004
Discontinued006
Discontinued007

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0GEOPENCARBENICILLIN DISODIUM
002INJECTABLE;INJECTIONEQ 5GM BASE/VIAL0GEOPENCARBENICILLIN DISODIUM
004INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0GEOPENCARBENICILLIN DISODIUM
006INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0GEOPENCARBENICILLIN DISODIUM
007INJECTABLE;INJECTIONEQ 30GM BASE/VIAL0GEOPENCARBENICILLIN DISODIUM

CDER Filings

ROERIG
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50306
            [companyName] => ROERIG
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEOPEN","activeIngredients":"CARBENICILLIN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEOPEN","activeIngredients":"CARBENICILLIN DISODIUM","strength":"EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEOPEN","activeIngredients":"CARBENICILLIN DISODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEOPEN","activeIngredients":"CARBENICILLIN DISODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GEOPEN","activeIngredients":"CARBENICILLIN DISODIUM","strength":"EQ 30GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEOPEN","submission":"CARBENICILLIN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GEOPEN","submission":"CARBENICILLIN DISODIUM","actionType":"EQ 5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GEOPEN","submission":"CARBENICILLIN DISODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GEOPEN","submission":"CARBENICILLIN DISODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GEOPEN","submission":"CARBENICILLIN DISODIUM","actionType":"EQ 30GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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