NDA 020729

UCB INC

FDA Drug Application

Application #020729

Documents

• Letter: 2002-02-14
• Letter: 2012-01-23
• Label: 2011-09-02
• Review: 2007-09-26
• Letter: 2003-11-25
• Letter: 2010-01-15
• Letter: 2011-08-26
• Letter: 2012-09-17
• Label: 2010-01-20
• Label: 2011-05-23
• Label: 2012-01-23
• Label: 2012-09-14

Application Sponsors

NDA 020729

UCB INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	UNIRETIC	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
002	TABLET;ORAL	25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	UNIRETIC	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
003	TABLET;ORAL	12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	UNIRETIC	HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-06-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	1998-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-10-29	STANDARD
LABELING; Labeling	SUPPL	5	AP	2000-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-02-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-10-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	2010-01-13	UNKNOWN
LABELING; Labeling	SUPPL	23	AP	2011-05-19	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2011-08-23	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	2012-01-19	UNKNOWN
LABELING; Labeling	SUPPL	26	AP	2012-09-13	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	21	Null	31
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	25	Null	6
SUPPL	26	Null	7

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20729
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"UNIRETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"12.5MG;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":"UNIRETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"25MG;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"},{"drugName":"UNIRETIC","activeIngredients":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","strength":"12.5MG;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\/13\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020729s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020729s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2011","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020729s024lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2011","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020729s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2010","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020729s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"UNIRETIC","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"12.5MG;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":"UNIRETIC","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"UNIRETIC","submission":"HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE","actionType":"12.5MG;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] => 2012-09-13
        )

)