NDA 017668

SANOFI AVENTIS US

FDA Drug Application

Application #017668

Application Sponsors

NDA 017668

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

TENUATE

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1975-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1976-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1976-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1978-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1980-05-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	1980-05-27
LABELING; Labeling	SUPPL	10	AP	1981-05-18

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17668
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENUATE","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENUATE","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)