NDA 009182

ROCHE

FDA Drug Application

Application #009182

Application Sponsors

NDA 009182

ROCHE

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 009

Application Products

002	SYRUP;ORAL	EQ 500MG BASE/5ML	0	GANTRISIN	SULFISOXAZOLE ACETYL
004	SUSPENSION;ORAL	EQ 500MG BASE/5ML	0	GANTRISIN PEDIATRIC	SULFISOXAZOLE ACETYL
009	EMULSION;ORAL	EQ 1GM BASE/5ML	0	LIPO GANTRISIN	SULFISOXAZOLE ACETYL

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1953-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1975-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1977-12-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	1978-01-27	STANDARD
LABELING; Labeling	SUPPL	16	AP	1982-05-25	STANDARD
LABELING; Labeling	SUPPL	17	AP	1993-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 9182
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANTRISIN","activeIngredients":"SULFISOXAZOLE ACETYL","strength":"EQ 500MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GANTRISIN PEDIATRIC","activeIngredients":"SULFISOXAZOLE ACETYL","strength":"EQ 500MG BASE\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LIPO GANTRISIN","activeIngredients":"SULFISOXAZOLE ACETYL","strength":"EQ 1GM BASE\/5ML","dosageForm":"EMULSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GANTRISIN","submission":"SULFISOXAZOLE ACETYL","actionType":"EQ 500MG BASE\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GANTRISIN PEDIATRIC","submission":"SULFISOXAZOLE ACETYL","actionType":"EQ 500MG BASE\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LIPO GANTRISIN","submission":"SULFISOXAZOLE ACETYL","actionType":"EQ 1GM BASE\/5ML","submissionClassification":"EMULSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)