NDA 011673

3M

FDA Drug Application

Application #011673

Application Sponsors

NDA 011673

3M

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

TEPANIL

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1959-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1975-09-09	STANDARD
LABELING; Labeling	SUPPL	10	AP	1985-02-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	1987-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11673
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPANIL","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TEPANIL","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)