FDA.reportPublic FDA data

Application 203093

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VITEKTAELVITEGRAVIRTABLET;ORAL85MGYesNo
002VITEKTAELVITEGRAVIRTABLET;ORAL150MGYesNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203093-001VITEKTAELVITEGRAVIR85MGTABLET / ORALRLD2014-09-24
N203093-002VITEKTAELVITEGRAVIR150MGTABLET / ORALRLD2014-09-24

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203093-00171762202026-08-27U-257Drug substance, Drug product2014-10-17
N203093-00176357042026-10-26U-257Drug substance, Drug product2014-10-17
N203093-00189811032026-10-26Drug substance, Drug product2015-04-14
N203093-0017176220*PED2027-02-27Pediatric extension
N203093-0017635704*PED2027-04-26Pediatric extension
N203093-0018981103*PED2027-04-26Pediatric extension
N203093-00271762202026-08-27U-257Drug substance, Drug product2014-10-17
N203093-00276357042026-10-26U-257Drug substance, Drug product2014-10-17
N203093-00289811032026-10-26Drug substance, Drug product2015-04-14
N203093-0027176220*PED2027-02-27Pediatric extension
N203093-0027635704*PED2027-04-26Pediatric extension
N203093-0028981103*PED2027-04-26Pediatric extension

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203093-001VITEKTA85MGTABLET / ORALRLD2014-09-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N203093-002VITEKTA150MGTABLET / ORALRLD2014-09-24782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203093-00171762202026-08-27U-257Drug substance, Drug product2014-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-00176357042026-10-26U-257Drug substance, Drug product2014-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-00189811032026-10-26Drug substance, Drug product2015-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0017176220*PED2027-02-27Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0017635704*PED2027-04-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0018981103*PED2027-04-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-00271762202026-08-27U-257Drug substance, Drug product2014-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-00276357042026-10-26U-257Drug substance, Drug product2014-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-00289811032026-10-26Drug substance, Drug product2015-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0027176220*PED2027-02-27Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0027635704*PED2027-04-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203093-0028981103*PED2027-04-26Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00171762202026-08-27U-257Drug substance, Drug product2014-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00176357042026-10-26U-257Drug substance, Drug product2014-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00189811032026-10-26Drug substance, Drug product2015-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0017176220*PED2027-02-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0017635704*PED2027-04-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0018981103*PED2027-04-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00271762202026-08-27U-257Drug substance, Drug product2014-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00276357042026-10-26U-257Drug substance, Drug product2014-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-00289811032026-10-26Drug substance, Drug product2015-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0027176220*PED2027-02-27Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0027635704*PED2027-04-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203093-0028981103*PED2027-04-26Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N203093-00171762202026-08-27U-257Drug substance, Drug product2014-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-00176357042026-10-26U-257Drug substance, Drug product2014-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-00189811032026-10-26Drug substance, Drug product2015-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0017176220*PED2027-02-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0017635704*PED2027-04-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0018981103*PED2027-04-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-00271762202026-08-27U-257Drug substance, Drug product2014-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-00276357042026-10-26U-257Drug substance, Drug product2014-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-00289811032026-10-26Drug substance, Drug product2015-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0027176220*PED2027-02-27Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0027635704*PED2027-04-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203093-0028981103*PED2027-04-26Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-00171762202026-08-27U-257Drug substance, Drug product2014-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-00176357042026-10-26U-257Drug substance, Drug product2014-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-00189811032026-10-26Drug substance, Drug product2015-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203093-0017176220*PED2027-02-27Pediatric extensionfd3edfee7708…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43420ORIG2016-03-28
40257SUPPL2015-07-30
10155SUPPL2015-07-28
19418ORIG2014-09-26
10154ORIG2014-09-26