NDA 010796

ABBVIE

FDA Drug Application

Application #010796

Application Sponsors

NDA 010796

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	0.1MG	0	HARMONYL	DESERPIDINE
002	TABLET;ORAL	0.25MG	0	HARMONYL	DESERPIDINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-04-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2009-03-13
LABELING; Labeling	SUPPL	8	AP	1980-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-07-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	1991-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-12-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	1984-03-05

Submissions Property Types

SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10796
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HARMONYL","activeIngredients":"DESERPIDINE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HARMONYL","activeIngredients":"DESERPIDINE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HARMONYL","submission":"DESERPIDINE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HARMONYL","submission":"DESERPIDINE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)