Application 202258

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VICTRELISBOCEPREVIRCAPSULE;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N202258-001VICTRELISBOCEPREVIR200MGCAPSULE / ORAL2011-05-13

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202258-00181196022027-03-17U-12332012-03-21
N202258-00177721782027-11-11U-1128Drug product2011-06-10

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202258-001VICTRELIS200MGCAPSULE / ORAL2011-05-13e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N202258-00181196022027-03-17U-12332012-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07N202258-00177721782027-11-11U-1128Drug product2011-06-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202258-00181196022027-03-17U-12332012-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202258-00177721782027-11-11U-1128Drug product2011-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202258-00181196022027-03-17U-12332012-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202258-00177721782027-11-11U-1128Drug product2011-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N202258-00181196022027-03-17U-12332012-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202258-00177721782027-11-11U-1128Drug product2011-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202258-00181196022027-03-17U-12332012-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202258-00177721782027-11-11U-1128Drug product2011-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202258-00181196022027-03-17U-12332012-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202258-00177721782027-11-11U-1128Drug product2011-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202258-001RE432982024-12-22U-1128Drug substance, Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202258-00181196022027-03-17U-12332012-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202258-00177721782027-11-11U-1128Drug product2011-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202258-001RE432982024-12-22U-1128Drug substance, Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202258-00181196022027-03-17U-12332012-03-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202258-00177721782027-11-11U-1128Drug product2011-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202258-001RE432982024-12-22U-1128Drug substance, Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202258-00181196022027-03-17U-12332012-03-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202258-00177721782027-11-11U-1128Drug product2011-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202258-001RE432982024-12-22U-1128Drug substance, Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202258-00181196022027-03-17U-12332012-03-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202258-00177721782027-11-11U-1128Drug product2011-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202258-001RE432982024-12-22U-1128Drug substance, Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N202258-00181196022027-03-17U-12332012-03-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N202258-00177721782027-11-11U-1128Drug product2011-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202258-001RE432982024-12-22U-1128Drug substance, Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202258-00181196022027-03-17U-12332012-03-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202258-00177721782027-11-11U-1128Drug product2011-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202258-001RE432982024-12-22U-1128Drug substance, Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202258-00181196022027-03-17U-12332012-03-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202258-00177721782027-11-11U-1128Drug product2011-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202258-001RE432982024-12-22U-1128Drug substance, Drug product1e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202258-00181196022027-03-17U-12332012-03-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202258-00177721782027-11-11U-1128Drug product2011-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202258-001RE432982024-12-22U-1128Drug substance, Drug product8072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202258-00181196022027-03-17U-12332012-03-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202258-00177721782027-11-11U-1128Drug product2011-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202258-001RE432982024-12-22U-1128Drug substance, Drug product5c6f7cd8ea54…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47070SUPPL2017-01-31
47064SUPPL2017-01-30
40152SUPPL2014-07-29
32219SUPPL2014-07-29
19304SUPPL2014-04-10
10004SUPPL2014-04-10
10006SUPPL2014-02-26
19306SUPPL2014-02-25
10005SUPPL2014-02-11
40151SUPPL2014-02-10
19305SUPPL2014-01-22
32218SUPPL2014-01-21
40150SUPPL2013-09-19
10003SUPPL2013-09-19
40148SUPPL2013-03-01
10001SUPPL2013-03-01
19303SUPPL2013-02-20
10002SUPPL2013-02-20
10000SUPPL2013-02-15
40147SUPPL2013-02-14
19302SUPPL2012-12-28
32217SUPPL2012-12-26
40149SUPPL2012-11-28
32216SUPPL2012-11-06
9998SUPPL2012-08-01
40145SUPPL2012-07-30
40146SUPPL2012-04-24
9999SUPPL2012-04-24
44430ORIG2012-02-13
44850ORIG2011-06-15
43391ORIG2011-06-15
23486ORIG2011-05-17
43557ORIG2011-05-13
40144ORIG2011-05-13
9997ORIG2011-05-13