FDA.reportPublic FDA data

Application 017681

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HIPREXMETHENAMINE HIPPURATETABLET;ORAL1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0955-1037Methenamine HippurateMethenamine HippurateWinthrop U.S.NDACurrent
30698-277HIPREXMethenamine HippurateValidus Pharmaceuticals LLCNDACurrent
30698-277HIPREXMethenamine HippurateValidus Pharmaceuticals LLCNDACurrent
30698-477HIPREXMethenamine HippurateValidus Pharmaceuticals LLCNDACurrent
69315-210Methenamine HippurateMethenamine HippurateLeading Pharma, LLCNDA AUTHORIZED GENERICCurrent
69315-210Methenamine HippurateMethenamine HippurateLeading Pharma, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70234SUPPL2022-02-23
70186SUPPL2022-02-18
50592SUPPL2017-12-04
50581SUPPL2017-12-01
33330SUPPL2005-11-30
682SUPPL2005-11-30
33329SUPPL2004-06-15
681SUPPL2004-06-15