NDA 018550

ROCHE

FDA Drug Application

Application #018550

Application Sponsors

NDA 018550

ROCHE

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET;ORAL	100MG	0	RIMADYL	CARPROFEN
003	TABLET;ORAL	150MG	0	RIMADYL	CARPROFEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-07-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	1995-02-27

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18550
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIMADYL","activeIngredients":"CARPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIMADYL","activeIngredients":"CARPROFEN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIMADYL","submission":"CARPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RIMADYL","submission":"CARPROFEN","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)