Home Applications 212839 Application 212839
Type NDA
Sponsor SK LIFE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XCOPRI CENOBAMATE TABLET;ORAL 12.5MG Yes No 002 XCOPRI CENOBAMATE TABLET;ORAL 25MG Yes No 003 XCOPRI CENOBAMATE TABLET;ORAL 50MG Yes No 004 XCOPRI CENOBAMATE TABLET;ORAL 100MG Yes No 005 XCOPRI CENOBAMATE TABLET;ORAL 150MG Yes No 006 XCOPRI CENOBAMATE TABLET;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212839-001 XCOPRI CENOBAMATE 12.5MG TABLET / ORAL RLD, RS 2020-03-10 N212839-002 XCOPRI CENOBAMATE 25MG TABLET / ORAL RLD 2020-03-10 N212839-003 XCOPRI CENOBAMATE 50MG TABLET / ORAL RLD 2020-03-10 N212839-004 XCOPRI CENOBAMATE 100MG TABLET / ORAL RLD 2020-03-10 N212839-005 XCOPRI CENOBAMATE 150MG TABLET / ORAL RLD 2020-03-10 N212839-006 XCOPRI CENOBAMATE 200MG TABLET / ORAL RLD 2020-03-10
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212839-001 7598279 2032-10-30 Drug substance 2020-03-12 N212839-001 11654133 2039-06-16 U-3610 2023-05-31 N212839-002 7598279 2032-10-30 Drug substance 2020-03-12 N212839-002 11654133 2039-06-16 U-3610 2023-05-31 N212839-003 7598279 2032-10-30 Drug substance 2020-03-12 N212839-003 11654133 2039-06-16 U-3610 2023-05-31 N212839-004 7598279 2032-10-30 Drug substance 2020-03-12 N212839-004 11654133 2039-06-16 U-3610 2023-05-31 N212839-005 7598279 2032-10-30 Drug substance 2020-03-12 N212839-005 11654133 2039-06-16 U-3610 2023-05-31 N212839-006 7598279 2032-10-30 Drug substance 2020-03-12 N212839-006 11654133 2039-06-16 U-3610 2023-05-31
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 6 · 234 observed 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 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-005 XCOPRI 150MG TABLET / ORAL RLD 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212839-006 XCOPRI 200MG TABLET / ORAL RLD 2020-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212839-001 XCOPRI 12.5MG TABLET / ORAL RLD, RS 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212839-002 XCOPRI 25MG TABLET / ORAL RLD 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212839-003 XCOPRI 50MG TABLET / ORAL RLD 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212839-004 XCOPRI 100MG TABLET / ORAL RLD 2020-03-10 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 10 · 378 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 N212839-001 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-001 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-002 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-002 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-003 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-003 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-004 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-004 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-005 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-005 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-006 7598279 2032-10-30 Drug substance 2020-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212839-006 11654133 2039-06-16 U-3610 2023-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212839-001 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-001 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-002 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-002 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-003 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-003 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-004 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-004 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-005 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-005 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-006 7598279 2032-10-30 Drug substance 2020-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212839-006 11654133 2039-06-16 U-3610 2023-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212839-001 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-001 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-002 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-002 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-003 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-003 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-004 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-004 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-005 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-005 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-006 7598279 2032-10-30 Drug substance 2020-03-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212839-006 11654133 2039-06-16 U-3610 2023-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-001 7598279 2032-10-30 Drug substance 2020-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-001 11654133 2039-06-16 U-3610 2023-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-002 7598279 2032-10-30 Drug substance 2020-03-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212839-002 11654133 2039-06-16 U-3610 2023-05-31 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 210 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 99 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71699-202 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-202 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-202 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-202 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-202 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-203 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-999 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-999 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-999 Xcopri cenobamate SK Life Science, Inc. NDA Current 71699-999 Xcopri cenobamate SK Life Science, Inc. NDA Current