Application 212887

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOCABRIACABOTEGRAVIRTABLET, FILM COATED30MGNoNo

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
N212887-001VOCABRIACABOTEGRAVIR SODIUMEQ 30MG BASETABLET / ORALRLD, RS2021-01-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212887-001109271292026-04-28Drug substance, Drug product2021-03-22
N212887-00184101032031-02-04U-3348Drug substance, Drug product2021-02-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N212887-001NCE2026-01-21

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 UTC2026-02N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-215aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212887-001VOCABRIAEQ 30MG BASETABLET / ORALRLD, RS2021-01-21a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212887-001109271292026-04-28Drug substance, Drug product2021-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212887-00184101032031-02-04U-3348Drug substance, Drug product2021-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-001109271292026-04-28Drug substance, Drug product2021-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-00184101032031-02-04U-3348Drug substance, Drug product2021-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N212887-001109271292026-04-28Drug substance, Drug product2021-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-001109271292026-04-28Drug substance, Drug product2021-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-001109271292026-04-28Drug substance, Drug product2021-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-001109271292026-04-28Drug substance, Drug product2021-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-001109271292026-04-28Drug substance, Drug product2021-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-001109271292026-04-28Drug substance, Drug product2021-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-001109271292026-04-28Drug substance, Drug product2021-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212887-001109271292026-04-28Drug substance, Drug product2021-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-001109271292026-04-28Drug substance, Drug product2021-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-001109271292026-04-28Drug substance, Drug product2021-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-001109271292026-04-28Drug substance, Drug product2021-03-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212887-001109271292026-04-28Drug substance, Drug product2021-03-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N212887-00184101032026-04-28U-3061Drug substance, Drug product2021-02-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N212887-00184101032026-04-28U-3348Drug substance, Drug product2021-02-168072bd15b7f6…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N212887-001NCE2026-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-001M-2732025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-001NPP2025-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212887-001NCE2026-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N212887-001M-2732025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212887-001NPP2025-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212887-001NCE2026-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-001M-2732025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-001NPP2025-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212887-001NCE2026-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-001M-2732025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-001NPP2025-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212887-001NCE2026-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-001M-2732025-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-001NPP2025-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212887-001NCE2026-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-001M-2732025-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-001NPP2025-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212887-001NCE2026-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-001M-2732025-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-001NPP2025-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212887-001NCE2026-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-001M-2732025-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-001NPP2025-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212887-001NCE2026-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212887-001M-2732025-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N212887-001NPP2025-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N212887-001NCE2026-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-001M-2732025-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-001NPP2025-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212887-001NCE2026-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-001M-2732025-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-001NPP2025-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212887-001NCE2026-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-001M-2732025-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-001NPP2025-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212887-001NCE2026-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212887-001M-2732025-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N212887-001NPP2025-03-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N212887-001NCE2026-01-218072bd15b7f6…

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
VocabriaCABOTEGRAVIR SODIUMViiV Healthcare Company66d450fb-cca4-476c-b0c7-c0730e3e4cf32025-04-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 212887
application number: NDA212887
ndc (product): 49702-248

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-248Vocabriacabotegravir sodiumViiV Healthcare CompanyNDACurrent
49702-248Vocabriacabotegravir sodiumViiV Healthcare CompanyNDACurrent
49702-248Vocabriacabotegravir sodiumViiV Healthcare CompanyNDACurrent
49702-248Vocabriacabotegravir sodiumViiV Healthcare CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82008SUPPL 2025-04-25
81943SUPPL 2025-04-21
79748SUPPL 2024-09-26
79747SUPPL 2024-09-26
79716SUPPL 2024-09-24
79715SUPPL 2024-09-24
76838SUPPL 2023-12-14
76810SUPPL 2023-12-14
76807SUPPL 2023-12-14
73624SUPPL 2023-02-28
73617SUPPL 2023-02-28
70659SUPPL2022-03-30
70658SUPPL2022-03-30
70651SUPPL2022-03-30
70650SUPPL2022-03-30
70599SUPPL2022-03-25
70594SUPPL2022-03-24
70142SUPPL2022-02-10
70129SUPPL2022-02-08
70059SUPPL2022-02-03
70043SUPPL2022-02-01
69735SUPPL2021-12-22
69732SUPPL2021-12-21
66473ORIG2021-03-03
66200ORIG2021-02-12
65963ORIG2021-01-22