Home Applications 209299 Application 209299
Type NDA
Sponsor RIGEL PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAVALISSE FOSTAMATINIB DISODIUM TABLET;ORAL EQ 100MG BASE Yes No 002 TAVALISSE FOSTAMATINIB DISODIUM TABLET;ORAL EQ 150MG BASE Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209299-001 TAVALISSE FOSTAMATINIB DISODIUM EQ 100MG BASE TABLET / ORAL AB RLD 2018-04-17 N209299-002 TAVALISSE FOSTAMATINIB DISODIUM EQ 150MG BASE TABLET / ORAL AB RLD, RS 2018-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 28 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 3 · 86 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 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL AB RLD 2018-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2018-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL AB RLD 2018-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL AB RLD, RS 2018-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209299-001 TAVALISSE EQ 100MG BASE TABLET / ORAL RLD 2018-04-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209299-002 TAVALISSE EQ 150MG BASE TABLET / ORAL RLD, RS 2018-04-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 31 · 1,204 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 N209299-001 8211889 2026-01-19 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 9266912 2026-01-19 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 RE48898 2026-01-19 Drug product 2022-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 7538108 2026-03-28 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 7989448 2026-06-12 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8163902 2026-06-17 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8445485 2026-06-17 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8912170 2026-06-17 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 9283238 2026-06-17 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8652492 2028-11-06 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8263122 2030-11-24 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 7449458 2031-09-04 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8771648 2032-07-27 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-001 8951504 2032-07-27 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8211889 2026-01-19 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 9266912 2026-01-19 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 RE48898 2026-01-19 Drug product 2022-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 7538108 2026-03-28 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 7989448 2026-06-12 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8163902 2026-06-17 U-2294 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8445485 2026-06-17 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8912170 2026-06-17 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 9283238 2026-06-17 U-2294 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8652492 2028-11-06 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8263122 2030-11-24 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 7449458 2031-09-04 Drug substance 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8771648 2032-07-27 Drug product 2018-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209299-002 8951504 2032-07-27 U-2294 2018-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209299-001 8211889 2026-01-19 Drug substance 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 9266912 2026-01-19 U-2294 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 RE48898 2026-01-19 Drug product 2022-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 7538108 2026-03-28 U-2294 Drug substance 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 7989448 2026-06-12 U-2294 Drug substance 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 8163902 2026-06-17 U-2294 Drug substance 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 8445485 2026-06-17 Drug product 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 8912170 2026-06-17 U-2294 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 9283238 2026-06-17 U-2294 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 8652492 2028-11-06 Drug product 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 8263122 2030-11-24 Drug product 2018-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209299-001 7449458 2031-09-04 Drug substance 2018-05-16 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-001 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current 71332-002 TAVALISSE FOSTAMATINIB Rigel Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 80975 SUPPL 2025-02-06 80972 SUPPL 2025-02-06 54188 ORIG 2018-05-15 53711 ORIG 2018-04-17 53706 ORIG 2018-04-17