Application 208712

Type: NDA
Sponsor: CTI BIOPHARMA CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VONJO	PACRITINIB	CAPSULE;ORAL	100MG	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
N208712-001	VONJO	PACRITINIB CITRATE	EQ 100MG BASE	CAPSULE / ORAL		RLD, RS	2022-02-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208712-001	9573964	2028-05-05	U-3331		2022-03-28
N208712-001	9573964	2028-05-05	U-3332		2022-03-28
N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28
N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28
N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28
N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208712-001	NCE	2027-02-28
N208712-001	ODE-397	2029-02-28

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.

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	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208712-001	VONJO	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2022-02-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 192 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	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	8980873	2030-03-25	U-3331	Drug substance, Drug product	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208712-001	8980873	2030-03-25	U-3332	Drug substance, Drug product	2022-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208712-001	9573964	2028-05-05	U-3332		2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208712-001	9573964	2028-05-05	U-3331		2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208712-001	8153632	2029-01-17	U-3332	Drug substance, Drug product	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208712-001	8153632	2029-01-17	U-3331	Drug substance, Drug product	2022-03-28	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208712-001	NCE	2027-02-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208712-001	ODE-397	2029-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208712-001	NCE	2027-02-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208712-001	ODE-397	2029-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208712-001	NCE	2027-02-28	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208712-001	ODE-397	2029-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208712-001	NCE	2027-02-28	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208712-001	ODE-397	2029-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208712-001	NCE	2027-02-28	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N208712-001	ODE-397	2029-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208712-001	NCE	2027-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208712-001	NCE	2027-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208712-001	NCE	2027-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208712-001	NCE	2027-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208712-001	NCE	2027-02-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208712-001	NCE	2027-02-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208712-001	ODE-397	2029-02-28	`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
Vonjo	PACRITINIB	Sobi, Inc.	4b5ab444-0e1a-4984-99db-76ad11a298ee	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208712 application number: NDA208712 ndc (product): 72482-100

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
72482-100	Vonjo	Pacritinib	CTI BioPharma Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85484	SUPPL	2026-03-24
85424	SUPPL	2026-03-20
83692	SUPPL	2025-10-08
83638	SUPPL	2025-10-03
83196	SUPPL	2025-08-26
83181	SUPPL	2025-08-25
80207	SUPPL	2024-11-14
80204	SUPPL	2024-11-13
75090	SUPPL	2023-08-16
75079	SUPPL	2023-08-16
71536	ORIG	2022-07-12
70634	ORIG	2022-03-29
70312	ORIG	2022-03-01