ANDA 085187

SANOFI AVENTIS US

FDA Drug Application

Application #085187

Application Sponsors

ANDA 085187

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

SYRUP;ORAL

80MG/15ML

0

SLO-PHYLLIN

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1979-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1983-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-09-01
LABELING; Labeling	SUPPL	21	AP	1990-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1993-03-04
LABELING; Labeling	SUPPL	23	AP	1993-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1993-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1993-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1999-04-29

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85187
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"SLO-PHYLLIN","activeIngredients":"THEOPHYLLINE","strength":"80MG\/15ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SLO-PHYLLIN","submission":"THEOPHYLLINE","actionType":"80MG\/15ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)