Application 208624

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIEKIRA XRDASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIRTABLET, EXTENDED RELEASE;ORALEQ 200MG BASE;8.33MG;50MG;33.33MGYesNo

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
N208624-001VIEKIRA XRDASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208624-00185012382028-09-17U-1636Drug substance, Drug product2016-08-17
N208624-00191395362028-11-09U-17532016-08-17
N208624-00181881042029-05-17U-1636Drug substance, Drug product2016-08-17
N208624-00186425382029-09-10U-1638Drug substance, Drug product2016-08-17
N208624-00190063872030-06-10U-16872016-08-17
N208624-00184205962031-04-10Drug substance, Drug product2016-08-17
N208624-00190444802031-04-10U-16382016-08-17
N208624-00186860262031-06-09Drug product2016-08-17
N208624-00186919382032-04-13Drug substance, Drug product2016-08-17
N208624-001102015412032-05-17Drug product2019-03-14
N208624-001102015842032-05-17U-18892019-03-14
N208624-00184661592032-09-04U-16372016-08-17
N208624-00184923862032-09-04U-18402016-08-17
N208624-00186801062032-09-04U-16372016-08-17
N208624-00186859842032-09-04U-18402016-08-17
N208624-001101053652035-01-02U-1889Drug product2018-11-20
N208624-00193332042035-01-02U-1889Drug product2016-08-17
N208624-00197441702035-01-02U-1889Drug product2017-09-27

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-223f01610625f2…
2019-09-15 20:21 UTC2019-09N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MGTABLET, EXTENDED RELEASE / ORALRLD2016-07-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208624-001VIEKIRA XREQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2016-07-22cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 21 · 818 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208624-00185012382028-09-17U-1636Drug substance, Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00191395362028-11-09U-17532016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00181881042029-05-17U-1636Drug substance, Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00186425382029-09-10U-1638Drug substance, Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00190063872030-06-10U-16872016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00184205962031-04-10Drug substance, Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00190444802031-04-10U-16382016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00186860262031-06-09Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00186919382032-04-13Drug substance, Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-001102015412032-05-17Drug product2019-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-001102015842032-05-17U-18892019-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00184661592032-09-04U-16372016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00184923862032-09-04U-18402016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00186801062032-09-04U-16372016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00186859842032-09-04U-18402016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-001101053652035-01-02U-1889Drug product2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00193332042035-01-02U-1889Drug product2016-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208624-00197441702035-01-02U-1889Drug product2017-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00185012382028-09-17U-1636Drug substance, Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00191395362028-11-09U-17532016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00181881042029-05-17U-1636Drug substance, Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00186425382029-09-10U-1638Drug substance, Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00190063872030-06-10U-16872016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00184205962031-04-10Drug substance, Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00190444802031-04-10U-16382016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00186860262031-06-09Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00186919382032-04-13Drug substance, Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-001102015412032-05-17Drug product2019-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-001102015842032-05-17U-18892019-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00184661592032-09-04U-16372016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00184923862032-09-04U-18402016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00186801062032-09-04U-16372016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00186859842032-09-04U-18402016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-001101053652035-01-02U-1889Drug product2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00193332042035-01-02U-1889Drug product2016-08-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208624-00197441702035-01-02U-1889Drug product2017-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N208624-00185012382028-09-17U-1636Drug substance, Drug product2016-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208624-00191395362028-11-09U-17532016-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208624-00181881042029-05-17U-1636Drug substance, Drug product2016-08-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208624-00186425382029-09-10U-1638Drug substance, Drug product2016-08-176a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208624-001NCE2019-12-1974a2ff9319b5…
2019-12-14 00:12 UTC2019-12N208624-001NCE2019-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09N208624-001NCE2019-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N208624-001NCE2019-12-19ea99ee380514…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-0063ViekiraDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-0063ViekiraDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent
0074-0063ViekiraDasabuvir and Ombitasvir and Paritaprevir and RitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61209SUPPL2019-12-10
61199SUPPL2019-12-09
61198SUPPL2019-12-09
55359SUPPL2018-08-29
55358SUPPL2018-08-29
54993SUPPL2018-07-26
50380SUPPL2017-11-13
48850ORIG2017-06-28
47672SUPPL2017-03-24
47671SUPPL2017-03-24
47641SUPPL2017-03-23
47640SUPPL2017-03-23
47225SUPPL2017-02-15
47210SUPPL2017-02-15
32913ORIG2016-07-26
19999ORIG2016-07-25