FDA.reportPublic FDA data

Application 220020

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YEZTUGOLENACAPAVIR SODIUMTABLET;ORALEQ 300MG BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220020-001YEZTUGOLENACAPAVIR SODIUMEQ 300MG BASETABLET / ORALRLD, RS2025-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220020-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11
N220020-001100719852037-08-17Drug substance, Drug product2025-07-11
N220020-001112677992038-08-16Drug substance2025-07-11

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220020-001NCE2027-12-22
N220020-001NP2028-06-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N220020-001YEZTUGOEQ 300MG BASETABLET / ORALRLD, RS2025-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-001YEZTUGOEQ 300MG BASETABLET / ORALRLD, RS2025-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220020-001YEZTUGOEQ 300MG BASETABLET / ORALRLD, RS2025-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-001YEZTUGOEQ 300MG BASETABLET / ORALRLD, RS2025-06-18a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N220020-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220020-001100719852037-08-17Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220020-001112677992038-08-16Drug substance2025-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-00199510432034-02-28U-4190Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-001100719852037-08-17Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-001112677992038-08-16Drug substance2025-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N220020-00199510432034-02-28U-4190Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220020-001100719852037-08-17Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220020-001112677992038-08-16Drug substance2025-07-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-001100719852037-08-17Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-001112677992038-08-16Drug substance2025-07-11a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N220020-001NCE2027-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220020-001NP2028-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-001NCE2027-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220020-001NP2028-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220020-001NCE2027-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220020-001NP2028-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-001NCE2027-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220020-001NP2028-06-18a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YeztugoLENACAPAVIR SODIUMGilead Sciences, Inc.1c241af1-ce62-4b0a-9eb7-f6b626174f012026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220020
application number: NDA220020

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83976ORIG 2025-10-29
82623ORIG 2025-06-20
82610ORIG 2025-06-20