NDA 019080

ABBOTT

FDA Drug Application

Application #019080

Documents

• Letter: 2004-06-10
• Other Important Information from FDA: 2007-03-16

Application Sponsors

NDA 019080

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PROSOM	ESTAZOLAM
002	TABLET;ORAL	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PROSOM	ESTAZOLAM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-12-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	1991-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-03-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	1993-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-05-08	STANDARD
LABELING; Labeling	SUPPL	7	AP	2004-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2003-01-06	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19080
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROSOM","activeIngredients":"ESTAZOLAM","strength":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PROSOM","activeIngredients":"ESTAZOLAM","strength":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROSOM","submission":"ESTAZOLAM","actionType":"1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PROSOM","submission":"ESTAZOLAM","actionType":"2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)