Application 215814

Type: NDA
Sponsor: FORMA THERAPEUTICS, INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REZLIDHIA	OLUTASIDENIB	CAPSULE; ORAL	150MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215814-001	REZLIDHIA	OLUTASIDENIB	150MG	CAPSULE / ORAL		RLD, RS	2022-12-01

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215814-001	10414752	2035-09-18		Drug product	2023-01-03
N215814-001	10550098	2035-09-18		Drug product	2023-01-03
N215814-001	11498913	2035-09-18		Drug product	2023-01-03
N215814-001	12275715	2035-09-18	U-3684	Drug substance, Drug product	2025-05-05
N215814-001	9834539	2035-09-18	U-3497	Drug substance, Drug product	2023-01-03
N215814-001	10532047	2039-05-16		Drug substance	2023-01-03
N215814-001	10959994	2039-05-16		Drug product	2023-01-03
N215814-001	11013733	2039-05-16	U-3496		2023-01-03
N215814-001	11013734	2039-05-16	U-3495		2023-01-03
N215814-001	11376246	2039-05-16	U-3495		2023-01-03
N215814-001	11497743	2039-05-16	U-3495		2023-01-03
N215814-001	12053463	2039-05-16		Drug substance, Drug product	2024-08-28
N215814-001	11738018	2039-07-17	U-3684		2023-09-14
N215814-001	11723905	2039-11-12		Drug product	2023-09-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215814-001	NCE	2027-12-01
N215814-001	ODE-413	2029-12-01

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215814-001	REZLIDHIA	150MG	CAPSULE / ORAL	RLD, RS	2022-12-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 323 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	N215814-001	10414752	2035-09-18		Drug product	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	10550098	2035-09-18		Drug product	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11498913	2035-09-18		Drug product	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	12275715	2035-09-18	U-3684	Drug substance, Drug product	2025-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	9834539	2035-09-18	U-3497	Drug substance, Drug product	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	10532047	2039-05-16		Drug substance	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	10959994	2039-05-16		Drug product	2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11013733	2039-05-16	U-3496		2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11013734	2039-05-16	U-3495		2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11376246	2039-05-16	U-3495		2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11497743	2039-05-16	U-3495		2023-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	12053463	2039-05-16		Drug substance, Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11738018	2039-07-17	U-3684		2023-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215814-001	11723905	2039-11-12		Drug product	2023-09-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215814-001	10414752	2035-09-18		Drug product	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	10550098	2035-09-18		Drug product	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11498913	2035-09-18		Drug product	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	12275715	2035-09-18	U-3684	Drug substance, Drug product	2025-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	9834539	2035-09-18	U-3497	Drug substance, Drug product	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	10532047	2039-05-16		Drug substance	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	10959994	2039-05-16		Drug product	2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11013733	2039-05-16	U-3496		2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11013734	2039-05-16	U-3495		2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11376246	2039-05-16	U-3495		2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11497743	2039-05-16	U-3495		2023-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	12053463	2039-05-16		Drug substance, Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11738018	2039-07-17	U-3684		2023-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215814-001	11723905	2039-11-12		Drug product	2023-09-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215814-001	10414752	2035-09-18		Drug product	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	10550098	2035-09-18		Drug product	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	11498913	2035-09-18		Drug product	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	12275715	2035-09-18	U-3684	Drug substance, Drug product	2025-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	9834539	2035-09-18	U-3497	Drug substance, Drug product	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	10532047	2039-05-16		Drug substance	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	10959994	2039-05-16		Drug product	2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	11013733	2039-05-16	U-3496		2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	11013734	2039-05-16	U-3495		2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	11376246	2039-05-16	U-3495		2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	11497743	2039-05-16	U-3495		2023-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215814-001	12053463	2039-05-16		Drug substance, Drug product	2024-08-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215814-001	NCE	2027-12-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215814-001	ODE-413	2029-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215814-001	NCE	2027-12-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215814-001	ODE-413	2029-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215814-001	NCE	2027-12-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215814-001	ODE-413	2029-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215814-001	NCE	2027-12-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N215814-001	ODE-413	2029-12-01	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215814-001	NCE	2027-12-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215814-001	ODE-413	2029-12-01	`a50c72e98297…`

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
REZLIDHIA	OLUTASIDENIB	Rigel Pharmaceuticals, Inc.	4a0c7c8b-b95f-455d-9600-b7351e4397fe	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215814 application number: NDA215814 ndc (product): 71332-005

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71332-005	REZLIDHIA	olutasidenib	Rigel Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73024	ORIG	2022-12-23
72825	ORIG	2022-12-08
72821	ORIG	2022-12-08
72765	ORIG	2022-12-02