NDA 017956

3M

FDA Drug Application

Application #017956

Application Sponsors

NDA 017956

3M

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

75MG

0

TEPANIL TEN-TAB

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1977-05-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	1980-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1980-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-02-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	1981-07-01
LABELING; Labeling	SUPPL	7	AP	1981-07-01
LABELING; Labeling	SUPPL	8	AP	1981-07-01
LABELING; Labeling	SUPPL	9	AP	1981-07-01
LABELING; Labeling	SUPPL	10	AP	1981-07-01
LABELING; Labeling	SUPPL	11	AP	1981-07-01
LABELING; Labeling	SUPPL	12	AP	1981-07-01
LABELING; Labeling	SUPPL	13	AP	1981-07-01
LABELING; Labeling	SUPPL	14	AP	1981-07-01
LABELING; Labeling	SUPPL	15	AP	1981-07-01
LABELING; Labeling	SUPPL	16	AP	1981-07-01
LABELING; Labeling	SUPPL	17	AP	2007-12-07
LABELING; Labeling	SUPPL	18	AP	1981-07-01
LABELING; Labeling	SUPPL	19	AP	1981-07-01
LABELING; Labeling	SUPPL	20	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1985-08-26	STANDARD
LABELING; Labeling	SUPPL	23	AP	1987-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1987-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-11-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17956
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPANIL TEN-TAB","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TEPANIL TEN-TAB","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)