NDA 008420

ROCHE

FDA Drug Application

Application #008420

Application Sponsors

NDA 008420

ROCHE

Marketing Status

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

Application Products

001	SYRUP;ORAL	50MG/5ML	0	RIMIFON	ISONIAZID
002	INJECTABLE;INJECTION	25MG/ML	0	RIMIFON	ISONIAZID
003	INJECTABLE;INJECTION	100MG/ML	0	RIMIFON	ISONIAZID

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 8420
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIMIFON","activeIngredients":"ISONIAZID","strength":"50MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIMIFON","activeIngredients":"ISONIAZID","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIMIFON","activeIngredients":"ISONIAZID","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIMIFON","submission":"ISONIAZID","actionType":"50MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIMIFON","submission":"ISONIAZID","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIMIFON","submission":"ISONIAZID","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)