NDA 020286

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020286

Documents

• Letter: 2009-02-13
• Letter: 2003-11-05

Application Sponsors

NDA 020286

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MONOPRIL-HCT	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MONOPRIL-HCT	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1994-11-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-05-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2001-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-03-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2003-10-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20286
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONOPRIL-HCT","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy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":"MONOPRIL-HCT","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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":"MONOPRIL-HCT","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"20MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MONOPRIL-HCT","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"10MG;12.5MG **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
        )

)