FDA.reportPublic FDA data

Application 212477

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HARVONILEDIPASVIR; SOFOSBUVIRPELLETS;ORAL33.75MG;150MG/PACKETYesNo
002HARVONILEDIPASVIR; SOFOSBUVIRPELLETS;ORAL45MG;200MG/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1804Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1805Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80686SUPPL 2024-12-23
80667SUPPL 2024-12-20
62686ORIG2020-04-27
62080SUPPL2020-03-09
62075SUPPL2020-03-06
61156SUPPL2019-12-05
60968SUPPL2019-11-19
60888SUPPL2019-11-19
60069SUPPL2019-09-20
60061SUPPL2019-09-20
59879ORIG2019-08-29
59871ORIG2019-08-29