Home Applications 022253 Application 022253
Type NDA
Sponsor UCB INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIMPAT LACOSAMIDE TABLET;ORAL 50MG Yes No 002 VIMPAT LACOSAMIDE TABLET;ORAL 100MG Yes No 003 VIMPAT LACOSAMIDE TABLET;ORAL 150MG Yes No 004 VIMPAT LACOSAMIDE TABLET;ORAL 200MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022253-001 VIMPAT LACOSAMIDE 50MG TABLET / ORAL AB RLD 2008-10-28 N022253-002 VIMPAT LACOSAMIDE 100MG TABLET / ORAL AB RLD 2008-10-28 N022253-003 VIMPAT LACOSAMIDE 150MG TABLET / ORAL AB RLD 2008-10-28 N022253-004 VIMPAT LACOSAMIDE 200MG TABLET / ORAL AB RLD, RS 2008-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 5 · 176 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 2026-10-15 13:18:30 2026-09 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-001 VIMPAT 50MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-002 VIMPAT 100MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-003 VIMPAT 150MG TABLET / ORAL AB RLD 2008-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022253-004 VIMPAT 200MG TABLET / ORAL AB RLD, RS 2008-10-28 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book patent history# Patent history page 2 of 8 · 296 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-04-04 05:41 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2140 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-1567 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2999 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2990 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-001 RE38551 2022-03-17 U-2989 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-1567 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2999 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2990 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2989 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-002 RE38551 2022-03-17 U-2140 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2140 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2999 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2989 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-2990 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-003 RE38551 2022-03-17 U-1567 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2140 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-1567 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2999 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2989 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022253-004 RE38551 2022-03-17 U-2990 Drug substance, Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022253-001 RE38551 2022-03-17 U-2140 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-001 RE38551 2022-03-17 U-1567 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-002 RE38551 2022-03-17 U-2140 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-002 RE38551 2022-03-17 U-1567 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-003 RE38551 2022-03-17 U-2140 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-003 RE38551 2022-03-17 U-1567 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-004 RE38551 2022-03-17 U-2140 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022253-004 RE38551 2022-03-17 U-1567 Drug substance, Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022253-001 RE38551 2022-03-17 U-2989 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-001 RE38551 2022-03-17 U-2990 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-001 RE38551 2022-03-17 U-2999 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-001 RE38551 2022-03-17 U-1567 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-001 RE38551 2022-03-17 U-2140 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-002 RE38551 2022-03-17 U-2140 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-002 RE38551 2022-03-17 U-2989 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-002 RE38551 2022-03-17 U-2990 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-002 RE38551 2022-03-17 U-2999 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-002 RE38551 2022-03-17 U-1567 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-003 RE38551 2022-03-17 U-1567 Drug substance, Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022253-003 RE38551 2022-03-17 U-2990 Drug substance, Drug product bb7c543d1eb4…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 280 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 1 of 1 · 55 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2470 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2477 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2478 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2479 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 0131-2480 Vimpat lacosamide UCB, Inc. NDA Current 70518-0257 Vimpat lacosamide REMEDYREPACK INC. NDA Current 70518-0257 Vimpat lacosamide REMEDYREPACK INC. NDA Current 70518-0257 Vimpat lacosamide REMEDYREPACK INC. NDA Current 70518-0257 Vimpat lacosamide REMEDYREPACK INC. NDA Current