FDA.reportPublic FDA data

Application 212950

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUKOBIAFOSTEMSAVIRTABLET, EXTENDED RELEASE;ORAL600MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-250Rukobiafostemsavir tromethamineViiV Healthcare CompanyNDACurrent
49702-250Rukobiafostemsavir tromethamineViiV Healthcare CompanyNDACurrent
49702-250Rukobiafostemsavir tromethamineViiV Healthcare CompanyNDACurrent
49702-250Rukobiafostemsavir tromethamineViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77504SUPPL 2024-02-15
77494SUPPL 2024-02-14
70063SUPPL2022-02-03
64122ORIG2020-07-29
63799ORIG2020-07-06
63790ORIG2020-07-06