TAVALISSE

Product NDC: 71332-002
Requested package NDC: 71332-002-01
11-digit product format: 713320002
Labeler code: 71332
Product ID: 71332-002_78828503-b88f-4e3d-9add-8b738c4cf28e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FOSTAMATINIB
Dosage form: TABLET
Route: ORAL
Labeler: Rigel Pharmaceuticals, Inc.
Application: NDA209299
Marketing category: NDA
Marketing start: 2018-05-09
Substance: FOSTAMATINIB
Active strength: 150 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: 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.

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209299-001	8211889	2026-01-19		Drug substance	2018-05-16
N209299-001	9266912	2026-01-19	U-2294		2018-05-16
N209299-001	RE48898	2026-01-19		Drug product	2022-02-23
N209299-001	7538108	2026-03-28	U-2294	Drug substance	2018-05-16
N209299-001	7989448	2026-06-12	U-2294	Drug substance	2018-05-16
N209299-001	8163902	2026-06-17	U-2294	Drug substance	2018-05-16
N209299-001	8445485	2026-06-17		Drug product	2018-05-16
N209299-001	8912170	2026-06-17	U-2294		2018-05-16
N209299-001	9283238	2026-06-17	U-2294		2018-05-16
N209299-001	8652492	2028-11-06		Drug product	2018-05-16
N209299-001	8263122	2030-11-24		Drug product	2018-05-16
N209299-001	7449458	2031-09-04		Drug substance	2018-05-16
N209299-001	8771648	2032-07-27		Drug product	2018-05-16
N209299-001	8951504	2032-07-27	U-2294		2018-05-16
N209299-002	8211889	2026-01-19		Drug substance	2018-05-16
N209299-002	9266912	2026-01-19	U-2294		2018-05-16
N209299-002	RE48898	2026-01-19		Drug product	2022-02-23
N209299-002	7538108	2026-03-28	U-2294	Drug substance	2018-05-16
N209299-002	7989448	2026-06-12	U-2294	Drug substance	2018-05-16
N209299-002	8163902	2026-06-17	U-2294	Drug substance	2018-05-16
N209299-002	8445485	2026-06-17		Drug product	2018-05-16
N209299-002	8912170	2026-06-17	U-2294		2018-05-16
N209299-002	9283238	2026-06-17	U-2294		2018-05-16
N209299-002	8652492	2028-11-06		Drug product	2018-05-16
N209299-002	8263122	2030-11-24		Drug product	2018-05-16
N209299-002	7449458	2031-09-04		Drug substance	2018-05-16
N209299-002	8771648	2032-07-27		Drug product	2018-05-16
N209299-002	8951504	2032-07-27	U-2294		2018-05-16

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
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209299-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209299-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209299-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209299-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209299-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209299-002	AB	1	`a50c72e98297…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209299-001	ODE-174	2025-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209299-002	ODE-174	2025-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209299-001	ODE-174	2025-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209299-002	ODE-174	2025-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209299-001	ODE-174	2025-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209299-002	ODE-174	2025-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209299-001	ODE-174	2025-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209299-002	ODE-174	2025-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209299-001	ODE-174	2025-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209299-002	ODE-174	2025-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209299-001	ODE-174	2025-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209299-002	ODE-174	2025-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209299-001	ODE-174	2025-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209299-002	ODE-174	2025-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209299-001	ODE-174	2025-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209299-002	ODE-174	2025-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209299-001	ODE-174	2025-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209299-002	ODE-174	2025-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209299-001	ODE-174	2025-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209299-002	ODE-174	2025-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209299-001	ODE-174	2025-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209299-002	ODE-174	2025-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209299-001	ODE-174	2025-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209299-002	ODE-174	2025-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209299-001	ODE-174	2025-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209299-002	ODE-174	2025-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209299-001	NCE	2023-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209299-001	ODE-174	2025-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209299-002	NCE	2023-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209299-002	ODE-174	2025-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209299-001	NCE	2023-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209299-001	ODE-174	2025-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209299-002	NCE	2023-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209299-002	ODE-174	2025-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209299-001	NCE	2023-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209299-001	ODE-174	2025-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209299-002	NCE	2023-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209299-002	ODE-174	2025-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209299-001	NCE	2023-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209299-001	ODE-174	2025-04-17	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TAVALISSE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSTAMATINIB	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SQ8A3S5101	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2044922	Internal RxNorm lookup
2044928	Internal RxNorm lookup
2044930	Internal RxNorm lookup
2044932	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
21149cc3-049b-43e2-b141-c9499160556c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ae789849-1b83-418d-9212-afc91d85b6a0	Product name	1	20180619
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-05-05	These highlights do not include all the information needed to use TAVALISSE ® safely and effectively. See full prescribing information for TAVALISSE. TAVALISSE ® (fostamatinib disodium hexahydrate) tablets, for oral use Initial U.S. Approval: 2018
2020-05-05	These highlights do not include all the information needed to use TAVALISSE ® safely and effectively. See full prescribing information for TAVALISSE. TAVALISSE ® (fostamatinib disodium hexahydrate) tablets, for oral use Initial U.S. Approval: 2018
2020-01-31	These highlights do not include all the information needed to use TAVALISSE ® safely and effectively. See full prescribing information for TAVALISSE. TAVALISSE ® (fostamatinib disodium hexahydrate) tablets, for oral use Initial U.S. Approval: 2018
2020-01-31	These highlights do not include all the information needed to use TAVALISSE ® safely and effectively. See full prescribing information for TAVALISSE. TAVALISSE ® (fostamatinib disodium hexahydrate) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71332-002-01	TAVALISSE	60 in 1 BOTTLE	TABLET	60		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71332-002-01	EA - Each	71332-002	7baabafc-b2aa-494e-a116-0a2c04674bc8	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71332-002	TAVALISSE (FOSTAMATINIB) TABLET [RIGEL PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20240830_21149cc3-049b-43e2-b141-c9499160556c.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAVALISSE	FOSTAMATINIB	Rigel Pharmaceuticals, Inc.	21149cc3-049b-43e2-b141-c9499160556c	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209299 application number: NDA209299 ndc (package): 71332-002-01 ndc (product): 71332-002 ndc11 (package): 71332000201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SQ8A3S5101	FOSTAMATINIB	901119-35-5	FOSTAMATINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2044922	fostamatinib 100 MG Oral Tablet	PSN	21149cc3-049b-43e2-b141-c9499160556c	11
2044930	fostamatinib 150 MG Oral Tablet	PSN	21149cc3-049b-43e2-b141-c9499160556c	11
2044928	Tavalisse 100 MG Oral Tablet	PSN	21149cc3-049b-43e2-b141-c9499160556c	11
2044932	Tavalisse 150 MG Oral Tablet	PSN	21149cc3-049b-43e2-b141-c9499160556c	11
2044928	fostamatinib 100 MG Oral Tablet [Tavalisse]	SBD	21149cc3-049b-43e2-b141-c9499160556c	11
2044932	fostamatinib 150 MG Oral Tablet [Tavalisse]	SBD	21149cc3-049b-43e2-b141-c9499160556c	11
2044922	fostamatinib 100 MG Oral Tablet	SCD	21149cc3-049b-43e2-b141-c9499160556c	11
2044930	fostamatinib 150 MG Oral Tablet	SCD	21149cc3-049b-43e2-b141-c9499160556c	11
2044922	fostamatinib 100 MG (equivalent to fostamatinib disodium 126.2 MG ) Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11
2044930	fostamatinib 150 MG (equivalent to 189.3 MG fostamatinib disodium) Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11
2044928	Tavalisse 100 MG (equivalent to fostamatinib disodium 126.2 MG) Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11
2044928	Tavalisse 100 MG Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11
2044932	Tavalisse 150 MG (equivalent to 189.3 MG fostamatinib disodium) Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11
2044932	Tavalisse 150 MG Oral Tablet	SY	21149cc3-049b-43e2-b141-c9499160556c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71332-002-01	71332000201	60 TABLET in 1 BOTTLE (71332-002-01)	60 tablet	2018-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TAVALISSE	Rigel Pharmaceuticals, Inc. \| Patheon Whitby	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	11