ANDA 085204

SANOFI AVENTIS US

FDA Drug Application

Application #085204

Application Sponsors

ANDA 085204

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

SLO-PHYLLIN

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1979-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-11-01
LABELING; Labeling	SUPPL	16	AP	1988-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1990-06-18
LABELING; Labeling	SUPPL	19	AP	1990-07-26
LABELING; Labeling	SUPPL	20	AP	1990-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-04-29

Submissions Property Types

ORIG	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85204
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"SLO-PHYLLIN","activeIngredients":"THEOPHYLLINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SLO-PHYLLIN","submission":"THEOPHYLLINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)