Home Applications 211280 Application 211280
Type NDA
Sponsor ELI LILLY AND CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 REYVOW LASMIDITAN SUCCINATE TABLET;ORAL 50MG Yes No 002 REYVOW LASMIDITAN SUCCINATE TABLET;ORAL 100MG Yes Yes 003 REYVOW LASMIDITAN SUCCINATE TABLET;ORAL 200MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211280-001 REYVOW LASMIDITAN SUCCINATE EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 N211280-002 REYVOW LASMIDITAN SUCCINATE EQ 100MG BASE TABLET / ORAL RLD 2020-01-31 N211280-003 REYVOW LASMIDITAN SUCCINATE EQ 200MG BASE TABLET / ORAL RLD 2020-12-18
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211280-001 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 N211280-001 12257246 2030-07-07 U-2718 2025-04-22 N211280-001 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 N211280-001 12071423 2040-07-06 Drug product 2024-09-20 N211280-002 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 N211280-002 12257246 2030-07-07 U-2718 2025-04-22 N211280-002 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 N211280-002 12071423 2040-07-06 Drug product 2024-09-20 N211280-003 7423050 2028-02-17 U-1719 Drug substance, Drug product 2021-07-28 N211280-003 12257246 2030-07-07 U-2718 2025-04-22 N211280-003 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28
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 2 of 3 · 118 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211280-001 REYVOW 50MG TABLET / ORAL RLD 2020-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211280-002 REYVOW 100MG TABLET / ORAL RLD, RS 2020-01-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211280-003 REYVOW 200MG TABLET / ORAL RLD 2020-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211280-001 REYVOW 50MG TABLET / ORAL RLD 2020-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N211280-002 REYVOW 100MG TABLET / ORAL RLD, RS 2020-01-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N211280-003 REYVOW 200MG TABLET / ORAL RLD 2020-12-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211280-001 REYVOW 50MG TABLET / ORAL RLD 2020-01-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N211280-002 REYVOW 100MG TABLET / ORAL RLD, RS 2020-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211280-001 REYVOW 50MG TABLET / ORAL RLD 2020-01-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N211280-002 REYVOW 100MG TABLET / ORAL RLD, RS 2020-01-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211280-002 REYVOW EQ 100MG BASE TABLET / ORAL RLD, RS 2020-01-31 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211280-003 REYVOW EQ 200MG BASE TABLET / ORAL RLD 2020-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211280-001 REYVOW EQ 50MG BASE TABLET / ORAL RLD 2020-01-31 1c564ffb4f44…
Observed Orange Book patent history# Patent history page 1 of 9 · 327 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N211280-001 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-001 12257246 2030-07-07 U-2718 2025-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-001 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-001 12071423 2040-07-06 Drug product 2024-09-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-002 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-002 12257246 2030-07-07 U-2718 2025-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-002 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-002 12071423 2040-07-06 Drug product 2024-09-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-003 7423050 2028-02-17 U-1719 Drug substance, Drug product 2021-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-003 12257246 2030-07-07 U-2718 2025-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N211280-003 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N211280-001 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-001 12257246 2030-07-07 U-2718 2025-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-001 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-001 12071423 2040-07-06 Drug product 2024-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-002 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-002 12257246 2030-07-07 U-2718 2025-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-002 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-002 12071423 2040-07-06 Drug product 2024-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-003 7423050 2028-02-17 U-1719 Drug substance, Drug product 2021-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-003 12257246 2030-07-07 U-2718 2025-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211280-003 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211280-001 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-001 12257246 2030-07-07 U-2718 2025-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-001 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-001 12071423 2040-07-06 Drug product 2024-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-002 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-002 12257246 2030-07-07 U-2718 2025-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-002 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-002 12071423 2040-07-06 Drug product 2024-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-003 7423050 2028-02-17 U-1719 Drug substance, Drug product 2021-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-003 12257246 2030-07-07 U-2718 2025-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211280-003 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211280-001 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-001 12257246 2030-07-07 U-2718 2025-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-001 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-001 12071423 2040-07-06 Drug product 2024-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-002 7423050 2028-02-17 U-1719 Drug substance, Drug product 2020-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-002 12257246 2030-07-07 U-2718 2025-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211280-002 11053214 2037-12-05 U-1719 Drug substance, Drug product 2021-07-28 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 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 · 26 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4312 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4491 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4736 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4736 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4736 Reyvow lasmiditan Eli Lilly and Company NDA Current 0002-4736 Reyvow lasmiditan Eli Lilly and Company NDA Current