NDA 017952

ROCHE

FDA Drug Application

Application #017952

Application Sponsors

NDA 017952

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	100MG	0	TRIMPEX	TRIMETHOPRIM
002	TABLET;ORAL	200MG	0	TRIMPEX 200	TRIMETHOPRIM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1980-05-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-10-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	1983-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1983-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1990-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-07-31	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17952
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMPEX","activeIngredients":"TRIMETHOPRIM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TRIMPEX 200","activeIngredients":"TRIMETHOPRIM","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMPEX","submission":"TRIMETHOPRIM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TRIMPEX 200","submission":"TRIMETHOPRIM","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)