NDA 050579

GLAXOSMITHKLINE

FDA Drug Application

Application #050579

Application Sponsors

NDA 050579

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	MONOCID	CEFONICID SODIUM
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	MONOCID	CEFONICID SODIUM
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	MONOCID	CEFONICID SODIUM
004	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	MONOCID	CEFONICID SODIUM

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50579
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONOCID","activeIngredients":"CEFONICID SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONOCID","activeIngredients":"CEFONICID SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONOCID","activeIngredients":"CEFONICID SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONOCID","activeIngredients":"CEFONICID SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MONOCID","submission":"CEFONICID SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MONOCID","submission":"CEFONICID SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MONOCID","submission":"CEFONICID SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MONOCID","submission":"CEFONICID SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)