Application 211280

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REYVOWLASMIDITAN SUCCINATETABLET;ORAL50MGYesNo
002REYVOWLASMIDITAN SUCCINATETABLET;ORAL100MGYesYes
003REYVOWLASMIDITAN SUCCINATETABLET;ORAL200MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211280-001REYVOWLASMIDITAN SUCCINATEEQ 50MG BASETABLET / ORALRLD2020-01-31
N211280-002REYVOWLASMIDITAN SUCCINATEEQ 100MG BASETABLET / ORALRLD2020-01-31
N211280-003REYVOWLASMIDITAN SUCCINATEEQ 200MG BASETABLET / ORALRLD2020-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211280-00174230502028-02-17U-1719Drug substance, Drug product2020-02-25
N211280-001122572462030-07-07U-27182025-04-22
N211280-001110532142037-12-05U-1719Drug substance, Drug product2021-07-28
N211280-001120714232040-07-06Drug product2024-09-20
N211280-00274230502028-02-17U-1719Drug substance, Drug product2020-02-25
N211280-002122572462030-07-07U-27182025-04-22
N211280-002110532142037-12-05U-1719Drug substance, Drug product2021-07-28
N211280-002120714232040-07-06Drug product2024-09-20
N211280-00374230502028-02-17U-1719Drug substance, Drug product2021-07-28
N211280-003122572462030-07-07U-27182025-04-22
N211280-003110532142037-12-05U-1719Drug substance, Drug product2021-07-28

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 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-3184e616aacf4f…
2026-09-14 22:38:342026-08N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD2020-01-3184e616aacf4f…
2026-09-14 22:38:342026-08N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD2020-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-002REYVOWEQ 100MG BASETABLET / ORALRLD, RS2020-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-003REYVOWEQ 200MG BASETABLET / ORALRLD2020-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211280-001REYVOWEQ 50MG BASETABLET / ORALRLD2020-01-31301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 8 · 316 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N211280-00174230502028-02-17U-1719Drug substance, Drug product2020-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N211280-001122572462030-07-07U-27182025-04-2284e616aacf4f…
2026-09-14 22:38:342026-08N211280-001110532142037-12-05U-1719Drug substance, Drug product2021-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N211280-001120714232040-07-06Drug product2024-09-2084e616aacf4f…
2026-09-14 22:38:342026-08N211280-00274230502028-02-17U-1719Drug substance, Drug product2020-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N211280-002122572462030-07-07U-27182025-04-2284e616aacf4f…
2026-09-14 22:38:342026-08N211280-002110532142037-12-05U-1719Drug substance, Drug product2021-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N211280-002120714232040-07-06Drug product2024-09-2084e616aacf4f…
2026-09-14 22:38:342026-08N211280-00374230502028-02-17U-1719Drug substance, Drug product2021-07-2884e616aacf4f…
2026-09-14 22:38:342026-08N211280-003122572462030-07-07U-27182025-04-2284e616aacf4f…
2026-09-14 22:38:342026-08N211280-003110532142037-12-05U-1719Drug substance, Drug product2021-07-2884e616aacf4f…
2026-08-18 06:07:402026-07N211280-00174230502028-02-17U-1719Drug substance, Drug product2020-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-001122572462030-07-07U-27182025-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-001110532142037-12-05U-1719Drug substance, Drug product2021-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-001120714232040-07-06Drug product2024-09-20caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-00274230502028-02-17U-1719Drug substance, Drug product2020-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-002122572462030-07-07U-27182025-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-002110532142037-12-05U-1719Drug substance, Drug product2021-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-002120714232040-07-06Drug product2024-09-20caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-00374230502028-02-17U-1719Drug substance, Drug product2021-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-003122572462030-07-07U-27182025-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211280-003110532142037-12-05U-1719Drug substance, Drug product2021-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211280-00174230502028-02-17U-1719Drug substance, Drug product2020-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-001122572462030-07-07U-27182025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-001110532142037-12-05U-1719Drug substance, Drug product2021-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-001120714232040-07-06Drug product2024-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-00274230502028-02-17U-1719Drug substance, Drug product2020-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-002122572462030-07-07U-27182025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-002110532142037-12-05U-1719Drug substance, Drug product2021-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-002120714232040-07-06Drug product2024-09-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-00374230502028-02-17U-1719Drug substance, Drug product2021-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-003122572462030-07-07U-27182025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211280-003110532142037-12-05U-1719Drug substance, Drug product2021-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-00174230502028-02-17U-1719Drug substance, Drug product2020-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-001122572462030-07-07U-27182025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-001110532142037-12-05U-1719Drug substance, Drug product2021-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-001120714232040-07-06Drug product2024-09-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-00274230502028-02-17U-1719Drug substance, Drug product2020-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-002122572462030-07-07U-27182025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-002110532142037-12-05U-1719Drug substance, Drug product2021-07-2831067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-001NCE2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-002NCE2025-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211280-003NCE2025-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N211280-001NCE2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211280-002NCE2025-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211280-003NCE2025-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-001NCE2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-002NCE2025-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211280-003NCE2025-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-001NCE2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-002NCE2025-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211280-003NCE2025-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-001NCE2025-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-002NCE2025-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211280-003NCE2025-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-001NCE2025-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-002NCE2025-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211280-003NCE2025-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-001NCE2025-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-002NCE2025-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211280-003NCE2025-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-001NCE2025-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-002NCE2025-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211280-003NCE2025-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211280-001NCE2025-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N211280-002NCE2025-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N211280-003NCE2025-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-001NCE2025-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-002NCE2025-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211280-003NCE2025-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211280-001NCE2025-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211280-002NCE2025-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211280-003NCE2025-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211280-001NCE2025-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211280-002NCE2025-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211280-003NCE2025-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211280-001NCE2025-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211280-002NCE2025-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N211280-003NCE2025-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211280-001NCE2025-01-315c6f7cd8ea54…

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
ReyvowLASMIDITANEli Lilly and Companyaea3358c-ff41-4490-9e6d-c7bf7b3de13f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 211280
application number: NDA211280
ndc (product): 0002-4312
ndc (product): 0002-4491

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4312ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4491ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent
0002-4736ReyvowlasmiditanEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72244SUPPL2022-10-05
72243SUPPL2022-10-05
72093SUPPL2022-09-16
71595SUPPL2022-07-19
71594SUPPL2022-07-19
71578SUPPL2022-07-18
69993SUPPL2022-01-28
68932ORIG2021-10-08
67713SUPPL2021-06-07
67710SUPPL2021-06-04
67709SUPPL2021-06-04
64066SUPPL2020-07-23
64065SUPPL2020-07-23
63975SUPPL2020-07-20
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