FDA.reportPublic FDA data

Application 216962

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYALEVFOSCARBIDOPA; FOSLEVODOPASOLUTION;SUBCUTANEOUS120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)YesYes

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
N216962-001VYALEVFOSCARBIDOPA; FOSLEVODOPA120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216962-001101740612035-10-21U-4030Drug product2024-11-14
N216962-001107308952035-10-21Drug substance2024-11-14
N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-14
N216962-001122513652040-06-10U-40302025-04-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216962-001NP2027-10-16

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 UTC2026-02N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-162680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-001VYALEV120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-10-16a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N216962-001101740612035-10-21U-4030Drug product2024-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216962-001107308952035-10-21Drug substance2024-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216962-001122513652040-06-10U-40302025-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-001101740612035-10-21U-4030Drug product2024-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-001107308952035-10-21Drug substance2024-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-001122513652040-06-10U-40302025-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N216962-001101740612035-10-21U-4030Drug product2024-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216962-001107308952035-10-21Drug substance2024-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216962-001122513652040-06-10U-40302025-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216962-001101740612035-10-21U-4030Drug product2024-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216962-001107308952035-10-21Drug substance2024-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216962-001101740612035-10-21U-4030Drug product2024-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216962-001107308952035-10-21Drug substance2024-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216962-001101740612035-10-21U-4030Drug product2024-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216962-001107308952035-10-21Drug substance2024-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216962-001101740612035-10-21U-4030Drug product2024-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216962-001107308952035-10-21Drug substance2024-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-142680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-001101740612035-10-21U-4030Drug product2024-11-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-001107308952035-10-21Drug substance2024-11-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-00194460592035-10-21U-4030Drug substance, Drug product2024-11-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-001122513652040-06-10U-40302025-04-10a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N216962-001NP2027-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216962-001NP2027-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216962-001NP2027-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216962-001NP2027-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216962-001NP2027-10-16b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216962-001NP2027-10-16a50c72e98297…

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
VyalevFOSCARBIDOPA/FOSLEVODOPAAbbVie Inc.28e806e4-951c-40a9-9f0c-d0929caf054c2026-03-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 216962
application number: NDA216962

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85513SUPPL 2026-03-24
85494SUPPL 2026-03-24
85454SUPPL 2026-03-23
82513ORIG 2025-06-10
79942ORIG 2024-10-21
79911ORIG 2024-10-17