NDA 020312

UCB INC

FDA Drug Application

Application #020312

Documents

• Letter: 2001-04-11
• Letter: 2003-11-25
• Letter: 2012-01-23
• Label: 2010-01-29
• Label: 2011-09-02
• Label: 2012-01-23
• Label: 2012-09-18
• Other Important Information from FDA: 2006-06-09
• Letter: 2010-01-15
• Letter: 2011-08-26
• Letter: 2012-09-18
• Review: 2002-09-13
• Review: 1995-04-19

Application Sponsors

NDA 020312

UCB INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	UNIVASC	MOEXIPRIL HYDROCHLORIDE
002	TABLET;ORAL	15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	UNIVASC	MOEXIPRIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-09-03	STANDARD
LABELING; Labeling	SUPPL	10	AP	1998-04-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1999-02-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-07-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2000-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-03-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2001-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-12-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-10-29	STANDARD
LABELING; Labeling	SUPPL	31	AP	2010-01-13	UNKNOWN
LABELING; Labeling	SUPPL	33	AP	2011-08-23	UNKNOWN
LABELING; Labeling	SUPPL	34	AP	2012-01-19	UNKNOWN
LABELING; Labeling	SUPPL	35	AP	2012-09-14	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	31	Null	7
SUPPL	33	Null	7
SUPPL	34	Null	31
SUPPL	35	Null	15

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20312
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"UNIVASC","activeIngredients":"MOEXIPRIL HYDROCHLORIDE","strength":"7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"UNIVASC","activeIngredients":"MOEXIPRIL HYDROCHLORIDE","strength":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/14\/2012","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020312s035lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020312s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2011","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020312s033lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2010","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020312s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"UNIVASC","submission":"MOEXIPRIL HYDROCHLORIDE","actionType":"7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"UNIVASC","submission":"MOEXIPRIL HYDROCHLORIDE","actionType":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-09-14
        )

)