FDA.reportPublic FDA data

Application 019481

Type
NDA
Sponsor
UNITED GUARDIAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RENACIDINCITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATESOLUTION;IRRIGATION6.602GM/100ML;198MG/100ML;3.177GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0327-0012Renacidincitric acid, gluconolactone and magnesium carbonateUnited-Guardian, Inc.NDACurrent
0327-0012Renacidincitric acid, gluconolactone and magnesium carbonateUnited-Guardian, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33759SUPPL2015-11-04
17415SUPPL2015-11-04
17414SUPPL2007-05-09