NDA 010653

3M

FDA Drug Application

Application #010653

Application Sponsors

NDA 010653

3M

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

DISIPAL

ORPHENADRINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1975-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-04-28	STANDARD

Submissions Property Types

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

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10653
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISIPAL","activeIngredients":"ORPHENADRINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISIPAL","submission":"ORPHENADRINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)