FDA.reportPublic FDA data

Application 016042

Type
NDA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;50MGNoNo
003DYAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;37.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0007-3650DYAZIDEhydrochlorothiazide and triamtereneGlaxoSmithKline LLCNDACurrent
0007-3650DYAZIDEhydrochlorothiazide and triamtereneGlaxoSmithKline LLCNDACurrent
0007-3650DYAZIDEhydrochlorothiazide and triamtereneGlaxoSmithKline LLCNDACurrent
0007-3650DYAZIDEhydrochlorothiazide and triamtereneGlaxoSmithKline LLCNDACurrent
0007-3650DYAZIDEhydrochlorothiazide and triamtereneGlaxoSmithKline LLCNDACurrent
55154-4510DYAZIDEhydrochlorothiazide and triamtereneCardinal HealthNDACurrent
65084-135DYAZIDEhydrochlorothiazide and triamtereneMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64434SUPPL2020-08-27
64349SUPPL2020-08-21
33141SUPPL2011-03-21
12967SUPPL2011-03-17
33140SUPPL2010-03-03
12966SUPPL2010-02-26
412SUPPL2007-05-29