NDA 018557

ROCHE

FDA Drug Application

Application #018557

Documents

• Label: 2004-04-05
• Letter: 2004-03-02
• Letter: 2003-05-29
• Review: 2006-10-25

Application Sponsors

NDA 018557

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;500MG

0

FANSIDAR

PYRIMETHAMINE; SULFADOXINE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	1981-10-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-07-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-10-26	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1985-07-24	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1985-07-24	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1985-07-24	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1985-07-24	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1987-04-30	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1987-11-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-06-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-08-14	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2004-02-26	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2003-04-27	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18557
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"FANSIDAR","activeIngredients":"PYRIMETHAMINE; SULFADOXINE","strength":"25MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/26\/2004","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/18557slr015_fansidar_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FANSIDAR","submission":"PYRIMETHAMINE; SULFADOXINE","actionType":"25MG;500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2004-02-26
        )

)