FDA.reportPublic FDA data

Application 220018

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YEZTUGOLENACAPAVIR SODIUMSOLUTION;SUBCUTANEOUSEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)YesYes
002YEZTUGOLENACAPAVIRSOLUTION;SUBCUTANEOUS463.5MG/1.5ML(309MG/ML)NoNo

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
N220018-001YEZTUGOLENACAPAVIR SODIUMEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11
N220018-001100719852037-08-17Drug substance, Drug product2025-07-11
N220018-001112677992038-08-16Drug substance2025-07-11
N220018-001125942672039-07-15Drug product2026-04-16
N220018-001118076252040-11-25U-41902025-07-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220018-001NCE2027-12-22
N220018-001NP2028-06-18

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 UTC2026-02N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, 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 UTC2026-02N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001100719852037-08-17Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001112677992038-08-16Drug substance2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001118076252040-11-25U-41902025-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001100719852037-08-17Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001112677992038-08-16Drug substance2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001118076252040-11-25U-41902025-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001100719852037-08-17Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001112677992038-08-16Drug substance2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001118076252040-11-25U-41902025-07-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001100719852037-08-17Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001112677992038-08-16Drug substance2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001125942672039-07-15Drug product2026-04-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001118076252040-11-25U-41902025-07-11a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N220018-001NCE2027-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001NP2028-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001NCE2027-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001NP2028-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-001NCE2027-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001NP2028-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001NCE2027-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001NP2028-06-18a50c72e98297…

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): 220018
application number: NDA220018

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83977ORIG 2025-10-29
82622ORIG 2025-06-20
82609ORIG 2025-06-20