NDA 017669

SANOFI AVENTIS US

FDA Drug Application

Application #017669

Application Sponsors

NDA 017669

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

75MG

0

TENUATE

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1975-03-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1976-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-11-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	1981-05-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17669
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENUATE","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENUATE","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)