NDA 050306

ROERIG

FDA Drug Application

Application #050306

Application Sponsors

NDA 050306

ROERIG

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 004
• Discontinued: 006
• Discontinued: 007

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	GEOPEN	CARBENICILLIN DISODIUM
002	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	0	GEOPEN	CARBENICILLIN DISODIUM
004	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	GEOPEN	CARBENICILLIN DISODIUM
006	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	GEOPEN	CARBENICILLIN DISODIUM
007	INJECTABLE;INJECTION	EQ 30GM BASE/VIAL	0	GEOPEN	CARBENICILLIN 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
        )

)