FDA.reportPublic FDA data

Application 011870

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIURILCHLOROTHIAZIDESUSPENSION;ORAL250MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-311DIURILCHLOROTHIAZIDESalix Pharmaceuticals, IncNDACurrent
65649-311DIURILCHLOROTHIAZIDESalix Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11975SUPPL2009-06-16
10785SUPPL2009-06-10
11974SUPPL2007-08-07
11973SUPPL2005-08-11
11972SUPPL2004-09-29