Application 020312

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UNIVASCMOEXIPRIL HYDROCHLORIDETABLET;ORAL7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002UNIVASCMOEXIPRIL HYDROCHLORIDETABLET;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0091-3707Univascmoexipril hydrochlorideUCB, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24764SUPPL2012-09-18
12438SUPPL2012-09-18
12437SUPPL2012-01-23
2324SUPPL2012-01-23
12436SUPPL2011-09-02
24763SUPPL2011-08-26
12435SUPPL2010-01-29
24762SUPPL2010-01-15
23575ORIG2006-06-09
2323SUPPL2003-11-25
41278ORIG2002-09-13
2322SUPPL2001-04-11
57395ORIG1995-04-19