FDA.reportPublic FDA data

Application 205834

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HARVONILEDIPASVIR; SOFOSBUVIRTABLET;ORAL90MG;400MGYesYes
002HARVONILEDIPASVIR; SOFOSBUVIRTABLET;ORAL45MG;200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1801HarvoniLEDIPASVIR and SOFOSBUVIRGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
61958-1803Harvoniledipasvir and sofosbuvirGilead Sciences, IncNDACurrent
72626-2601Ledipasvir and SofosbuvirLedipasvir and SofosbuvirAsegua Therapeutics LLCNDA AUTHORIZED GENERICCurrent
72626-2601Ledipasvir and SofosbuvirLedipasvir and SofosbuvirAsegua Therapeutics LLCNDA AUTHORIZED GENERICCurrent
72626-2601Ledipasvir and SofosbuvirLedipasvir and SofosbuvirAsegua Therapeutics LLCNDA AUTHORIZED GENERICCurrent
72626-2601Ledipasvir and SofosbuvirLedipasvir and SofosbuvirAsegua Therapeutics LLCNDA AUTHORIZED GENERICCurrent
72626-2601Ledipasvir and SofosbuvirLedipasvir and SofosbuvirAsegua Therapeutics LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80685SUPPL 2024-12-23
80666SUPPL 2024-12-20
62079SUPPL2020-03-09
62074SUPPL2020-03-06
60967SUPPL2019-11-19
60887SUPPL2019-11-19
60068SUPPL2019-09-20
60060SUPPL2019-09-20
59885SUPPL2019-08-30
59872SUPPL2019-08-29
50393SUPPL2017-11-13
50375SUPPL2017-11-13
47980SUPPL2017-04-12
47920SUPPL2017-04-10
47218SUPPL2017-02-15
47213SUPPL2017-02-15
40513SUPPL2016-06-13
32744SUPPL2016-06-09
32745SUPPL2016-03-31
40514SUPPL2016-03-30
44934SUPPL2016-03-03
44933SUPPL2016-03-03
24508SUPPL2016-03-03
40512SUPPL2016-02-25
40511SUPPL2016-02-25
19690SUPPL2016-02-25
32743SUPPL2016-02-16
10514SUPPL2016-02-16
10513SUPPL2016-02-16
40510SUPPL2015-11-19
40509SUPPL2015-11-19
40508SUPPL2015-11-19
40507SUPPL2015-11-19
19689SUPPL2015-11-19
32742SUPPL2015-11-16
32741SUPPL2015-11-16
10512SUPPL2015-11-16
10511SUPPL2015-11-16
10510SUPPL2015-11-16
40506SUPPL2015-03-24
32740SUPPL2015-03-24
44932ORIG2014-11-03
43504ORIG2014-11-03
40505ORIG2014-10-15
10509ORIG2014-10-14
64115ORIG1900-01-01
64114ORIG1900-01-01
64113ORIG1900-01-01
64112ORIG1900-01-01
51287SUPPL1900-01-01
51286SUPPL1900-01-01
51285SUPPL1900-01-01