FDA.reportPublic FDA data

Application 217684

Type
NDA
Sponsor
PYROS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIGAFYDEVIGABATRINSOLUTION;ORAL100MG/MLYesYes

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
N217684-001VIGAFYDEVIGABATRIN100MG/MLSOLUTION / ORALRLD, RS2024-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217684-001120168572039-08-16Drug product2024-07-01
N217684-001122904992042-10-17Drug product2025-05-13
N217684-001125760542043-06-08Drug product2026-03-23

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
2026-08-18 06:07:402026-07N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217684-001VIGAFYDE100MG/MLSOLUTION / ORALRLD, RS2024-06-17a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N217684-001120168572039-08-16Drug product2024-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07N217684-001122904992042-10-17Drug product2025-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N217684-001125760542043-06-08Drug product2026-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217684-001120168572039-08-16Drug product2024-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217684-001122904992042-10-17Drug product2025-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217684-001120168572039-08-16Drug product2024-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217684-001122904992042-10-17Drug product2025-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N217684-001120168572039-08-16Drug product2024-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217684-001122904992042-10-17Drug product2025-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217684-001120168572039-08-16Drug product2024-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217684-001120168572039-08-16Drug product2024-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217684-001120168572039-08-16Drug product2024-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217684-001120168572039-08-16Drug product2024-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217684-001120168572039-08-16Drug product2024-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217684-001120168572039-08-16Drug product2024-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217684-001120168572039-08-16Drug product2024-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217684-001120168572039-08-16Drug product2024-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217684-001120168572039-08-16Drug product2024-07-01301d65b070ca…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217684-001120168572039-08-16Drug product2024-07-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217684-001122904992042-10-17Drug product2025-05-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217684-001125760542043-06-08Drug product2026-03-23a50c72e98297…

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
VIGAFYDEVIGABATRINUpsher-Smith Laboratories, LLC8d3d6316-33ab-41e8-9485-4495c218be562025-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217684
application number: NDA217684

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85616SUPPL 2026-04-01
83293SUPPL 2025-09-05
83292SUPPL 2025-09-05
83291SUPPL 2025-09-05
83280SUPPL 2025-09-04
83279SUPPL 2025-09-04
82202ORIG 2025-05-19
79620SUPPL 2024-09-16
78818ORIG 2024-06-18
78817ORIG 2024-06-18