Home Applications 218784 Application 218784
Type NDA
Sponsor SERVIER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VORANIGO VORASIDENIB TABLET;ORAL 10MG Yes No 002 VORANIGO VORASIDENIB TABLET;ORAL 40MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218784-001 VORANIGO VORASIDENIB 10MG TABLET / ORAL RLD 2024-08-06 N218784-002 VORANIGO VORASIDENIB 40MG TABLET / ORAL RLD, RS 2024-08-06
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218784-001 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 N218784-001 12433895 2034-07-11 U-4286 2025-10-22 N218784-001 9579324 2034-07-11 Drug substance 2024-08-27 N218784-001 11844758 2035-12-04 U-3977 2024-08-27 N218784-001 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 N218784-002 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 N218784-002 12433895 2034-07-11 U-4286 2025-10-22 N218784-002 9579324 2034-07-11 Drug substance 2024-08-27 N218784-002 11844758 2035-12-04 U-3977 2024-08-27 N218784-002 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218784-001 VORANIGO 10MG TABLET / ORAL RLD 2024-08-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218784-002 VORANIGO 40MG TABLET / ORAL RLD, RS 2024-08-06 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 114 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218784-001 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-001 12433895 2034-07-11 U-4286 2025-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-001 9579324 2034-07-11 Drug substance 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-001 11844758 2035-12-04 U-3977 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-001 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 12433895 2034-07-11 U-4286 2025-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 9579324 2034-07-11 Drug substance 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 11844758 2035-12-04 U-3977 2024-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218784-002 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218784-001 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-001 12433895 2034-07-11 U-4286 2025-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-001 9579324 2034-07-11 Drug substance 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-001 11844758 2035-12-04 U-3977 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-001 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 12433895 2034-07-11 U-4286 2025-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 9579324 2034-07-11 Drug substance 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 11844758 2035-12-04 U-3977 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218784-002 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218784-001 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-001 12433895 2034-07-11 U-4286 2025-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-001 9579324 2034-07-11 Drug substance 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-001 11844758 2035-12-04 U-3977 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-001 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 12433895 2034-07-11 U-4286 2025-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 9579324 2034-07-11 Drug substance 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 11844758 2035-12-04 U-3977 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218784-002 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 12433895 2034-07-11 U-4286 2025-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 9579324 2034-07-11 Drug substance 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 11844758 2035-12-04 U-3977 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-001 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 10172864 2034-07-11 Drug substance, Drug product 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 12433895 2034-07-11 U-4286 2025-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 9579324 2034-07-11 Drug substance 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 11844758 2035-12-04 U-3977 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218784-002 11345677 2039-01-16 U-3978 Drug substance, Drug product 2024-08-27 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 81901 SUPPL 2025-04-09 81882 SUPPL 2025-04-08 79491 ORIG 2024-08-28 79342 ORIG 2024-08-08 79337 ORIG 2024-08-08