ROCHE FDA Approval NDA 009182

NDA 009182

ROCHE

FDA Drug Application

Application #009182

Application Sponsors

NDA 009182ROCHE

Marketing Status

Discontinued002
Discontinued004
Discontinued009

Application Products

002SYRUP;ORALEQ 500MG BASE/5ML0GANTRISINSULFISOXAZOLE ACETYL
004SUSPENSION;ORALEQ 500MG BASE/5ML0GANTRISIN PEDIATRICSULFISOXAZOLE ACETYL
009EMULSION;ORALEQ 1GM BASE/5ML0LIPO GANTRISINSULFISOXAZOLE ACETYL

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP1953-12-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1975-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1977-12-22STANDARD
LABELING; LabelingSUPPL14AP1978-01-27STANDARD
LABELING; LabelingSUPPL16AP1982-05-25STANDARD
LABELING; LabelingSUPPL17AP1993-08-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1995-07-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1996-12-23STANDARD

Submissions Property Types

ORIG1Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0
SUPPL20Null0

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.