Application 209299

Type
NDA
Sponsor
RIGEL PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAVALISSEFOSTAMATINIB DISODIUMTABLET;ORALEQ 100MG BASEYesNo
002TAVALISSEFOSTAMATINIB DISODIUMTABLET;ORALEQ 150MG BASEYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209299-001TAVALISSEFOSTAMATINIB DISODIUMEQ 100MG BASETABLET / ORALABRLD2018-04-17
N209299-002TAVALISSEFOSTAMATINIB DISODIUMEQ 150MG BASETABLET / ORALABRLD, RS2018-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N209299-001AB
N209299-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209299-00182118892026-01-19Drug substance2018-05-16
N209299-00192669122026-01-19U-22942018-05-16
N209299-001RE488982026-01-19Drug product2022-02-23
N209299-00175381082026-03-28U-2294Drug substance2018-05-16
N209299-00179894482026-06-12U-2294Drug substance2018-05-16
N209299-00181639022026-06-17U-2294Drug substance2018-05-16
N209299-00184454852026-06-17Drug product2018-05-16
N209299-00189121702026-06-17U-22942018-05-16
N209299-00192832382026-06-17U-22942018-05-16
N209299-00186524922028-11-06Drug product2018-05-16
N209299-00182631222030-11-24Drug product2018-05-16
N209299-00174494582031-09-04Drug substance2018-05-16
N209299-00187716482032-07-27Drug product2018-05-16
N209299-00189515042032-07-27U-22942018-05-16
N209299-00282118892026-01-19Drug substance2018-05-16
N209299-00292669122026-01-19U-22942018-05-16
N209299-002RE488982026-01-19Drug product2022-02-23
N209299-00275381082026-03-28U-2294Drug substance2018-05-16
N209299-00279894482026-06-12U-2294Drug substance2018-05-16
N209299-00281639022026-06-17U-2294Drug substance2018-05-16
N209299-00284454852026-06-17Drug product2018-05-16
N209299-00289121702026-06-17U-22942018-05-16
N209299-00292832382026-06-17U-22942018-05-16
N209299-00286524922028-11-06Drug product2018-05-16
N209299-00282631222030-11-24Drug product2018-05-16
N209299-00274494582031-09-04Drug substance2018-05-16
N209299-00287716482032-07-27Drug product2018-05-16
N209299-00289515042032-07-27U-22942018-05-16

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N209299-001TAVALISSEEQ 100MG BASETABLET / ORALABRLD2018-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N209299-002TAVALISSEEQ 150MG BASETABLET / ORALABRLD, RS2018-04-1784e616aacf4f…
2026-08-18 06:07:402026-07N209299-001TAVALISSEEQ 100MG BASETABLET / ORALABRLD2018-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-002TAVALISSEEQ 150MG BASETABLET / ORALABRLD, RS2018-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209299-001TAVALISSEEQ 100MG BASETABLET / ORALRLD2018-04-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209299-002TAVALISSEEQ 150MG BASETABLET / ORALRLD, RS2018-04-1774a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N209299-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N209299-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N209299-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209299-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209299-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,204 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209299-00182118892026-01-19Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00192669122026-01-19U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-001RE488982026-01-19Drug product2022-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N209299-00175381082026-03-28U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00179894482026-06-12U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00181639022026-06-17U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00184454852026-06-17Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00189121702026-06-17U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00192832382026-06-17U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00186524922028-11-06Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00182631222030-11-24Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00174494582031-09-04Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00187716482032-07-27Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00189515042032-07-27U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00282118892026-01-19Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00292669122026-01-19U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-002RE488982026-01-19Drug product2022-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N209299-00275381082026-03-28U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00279894482026-06-12U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00281639022026-06-17U-2294Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00284454852026-06-17Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00289121702026-06-17U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00292832382026-06-17U-22942018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00286524922028-11-06Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00282631222030-11-24Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00274494582031-09-04Drug substance2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00287716482032-07-27Drug product2018-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N209299-00289515042032-07-27U-22942018-05-1684e616aacf4f…
2026-08-18 06:07:402026-07N209299-00182118892026-01-19Drug substance2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00192669122026-01-19U-22942018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-001RE488982026-01-19Drug product2022-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00175381082026-03-28U-2294Drug substance2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00179894482026-06-12U-2294Drug substance2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00181639022026-06-17U-2294Drug substance2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00184454852026-06-17Drug product2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00189121702026-06-17U-22942018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00192832382026-06-17U-22942018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00186524922028-11-06Drug product2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00182631222030-11-24Drug product2018-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N209299-00174494582031-09-04Drug substance2018-05-16caaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-09-29 23:25 UTC2022-09N209299-002NCE2023-04-17e64feba35796…
2022-09-29 23:25 UTC2022-09N209299-002ODE-1742025-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209299-001NCE2023-04-17cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209299-001ODE-1742025-04-17cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209299-002NCE2023-04-17cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209299-002ODE-1742025-04-17cb3db0bc1861…

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
TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.21149cc3-049b-43e2-b141-c9499160556c2025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 209299
application number: NDA209299
ndc (product): 71332-001
ndc (product): 71332-002

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-001TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent
71332-002TAVALISSEFOSTAMATINIBRigel Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80975SUPPL 2025-02-06
80972SUPPL 2025-02-06
54188ORIG2018-05-15
53711ORIG2018-04-17
53706ORIG2018-04-17