ANDA 089540

SANOFI AVENTIS US

FDA Drug Application

Application #089540

Application Sponsors

ANDA 089540

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

125MG

0

SLO-BID

THEOPHYLLINE

FDA Submissions

	ORIG	1	AP	1989-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-05-30
LABELING; Labeling	SUPPL	6	AP	1990-08-10
LABELING; Labeling	SUPPL	7	AP	1990-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-03-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-12-01

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89540
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"SLO-BID","activeIngredients":"THEOPHYLLINE","strength":"125MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SLO-BID","submission":"THEOPHYLLINE","actionType":"125MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)