Application 203469

Type: NDA
Sponsor: ARIAD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	Yes	No
002	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 45MG BASE	Yes	Yes
003	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 30MG BASE	Yes	No
004	ICLUSIG	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N203469-001	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14
N203469-002	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	RLD	2012-12-14
N203469-003	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23
N203469-004	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2020-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203469-001	9029533	2026-12-22	U-1283		2015-06-09
N203469-001	9029533	2026-12-22	U-1699		2015-06-09
N203469-001	9029533	2026-12-22	U-1700		2015-06-09
N203469-001	9029533	2026-12-22	U-1701		2015-06-09
N203469-001	9029533	2026-12-22	U-836		2015-06-09
N203469-001	8114874	2027-01-24		Drug substance, Drug product
N203469-001	11192895	2033-12-12	U-1700		2022-01-06
N203469-001	11192895	2033-12-12	U-1701		2022-01-06
N203469-001	11192895	2033-12-12	U-1948		2022-01-06
N203469-001	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-001	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-001	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-001	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-001	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-001	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-001	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-001	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-002	9029533	2026-12-22	U-1283		2015-06-09
N203469-002	9029533	2026-12-22	U-1699		2015-06-09
N203469-002	9029533	2026-12-22	U-1700		2015-06-09
N203469-002	9029533	2026-12-22	U-1701		2015-06-09
N203469-002	9029533	2026-12-22	U-836		2015-06-09
N203469-002	8114874	2027-01-24		Drug substance, Drug product
N203469-002	11192895	2033-12-12	U-1700		2022-01-06
N203469-002	11192895	2033-12-12	U-1701		2022-01-06
N203469-002	11192895	2033-12-12	U-1948		2022-01-06
N203469-002	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-002	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-002	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-002	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-002	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-002	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-002	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-002	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-003	9029533	2026-12-22	U-1283		2015-06-09
N203469-003	9029533	2026-12-22	U-1699		2015-06-09
N203469-003	9029533	2026-12-22	U-1700		2015-06-09
N203469-003	9029533	2026-12-22	U-1701		2015-06-09
N203469-003	9029533	2026-12-22	U-836		2015-06-09
N203469-003	8114874	2027-01-24		Drug substance, Drug product	2015-06-09
N203469-003	11192895	2033-12-12	U-1700		2022-01-06
N203469-003	11192895	2033-12-12	U-1701		2022-01-06
N203469-003	11192895	2033-12-12	U-1948		2022-01-06
N203469-003	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-003	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-003	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-003	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-003	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-003	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-003	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-003	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-004	9029533	2026-12-22	U-1283		2021-01-14
N203469-004	9029533	2026-12-22	U-1699		2021-01-14
N203469-004	9029533	2026-12-22	U-1700		2021-01-14
N203469-004	9029533	2026-12-22	U-1701		2021-01-14
N203469-004	9029533	2026-12-22	U-836		2021-01-14
N203469-004	8114874	2027-01-24		Drug substance, Drug product	2021-01-14
N203469-004	11192895	2033-12-12	U-1700		2022-01-06
N203469-004	11192895	2033-12-12	U-1701		2022-01-06
N203469-004	11192895	2033-12-12	U-1948		2022-01-06
N203469-004	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-004	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-004	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-004	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-004	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-004	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-004	9493470	2033-12-12	U-1700	Drug substance, Drug product	2021-01-14
N203469-004	9493470	2033-12-12	U-1948	Drug substance, Drug product	2021-01-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203469-001	I-934	2027-03-19
N203469-001	ODE-472	2031-03-19
N203469-002	I-934	2027-03-19
N203469-002	ODE-472	2031-03-19
N203469-003	I-934	2027-03-19
N203469-003	ODE-472	2031-03-19
N203469-004	I-934	2027-03-19
N203469-004	ODE-472	2031-03-19

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 4 · 158 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 59 · 2,356 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	8114874	2027-01-24		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1700		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1701		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1948		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1700	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1701	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1948	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	8114874	2027-01-24		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1700		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1701		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1948		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1700	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1701	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1948	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	8114874	2027-01-24		Drug substance, Drug product	2015-06-09	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203469-001	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	ODE-472	2031-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	ODE-472	2031-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203469-001	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-001	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	ODE-472	2031-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	ODE-472	2031-03-19	`b8a1b40f171c…`

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
Iclusig	PONATINIB HYDROCHLORIDE	Takeda Pharmaceuticals America, Inc.	16d804b6-4957-43ee-b18c-3b36ec37c5ac	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203469 application number: NDA203469 ndc (product): 63020-535 ndc (product): 63020-534 ndc (product): 63020-536 ndc (product): 63020-533

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-533	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-534	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-535	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-536	Iclusig	ponatinib hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current
76189-533	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current
76189-534	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current
76189-535	Iclusig	ponatinib hydrochloride	ARIAD Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83754	SUPPL	2025-10-15
83731	SUPPL	2025-10-14
83730	SUPPL	2025-10-14
77883	SUPPL	2024-03-20
77863	SUPPL	2024-03-19
70177	SUPPL	2022-02-16
70176	SUPPL	2022-02-16
70174	SUPPL	2022-02-16
65676	SUPPL	2020-12-22
65634	SUPPL	2020-12-21
65626	SUPPL	2020-12-18
63887	SUPPL	2020-07-14
63886	SUPPL	2020-07-14
63856	SUPPL	2020-07-13
63645	SUPPL	2020-06-19
63644	SUPPL	2020-06-19
63627	SUPPL	2020-06-19
61575	SUPPL	2020-01-14
61574	SUPPL	2020-01-14
61561	SUPPL	2020-01-14
56128	SUPPL	2018-10-29
56127	SUPPL	2018-10-26
56078	SUPPL	2018-10-23
54386	SUPPL	2018-05-31
50909	SUPPL	2017-12-27
50907	SUPPL	2017-12-27
50851	SUPPL	2017-12-26
50850	SUPPL	2017-12-26
46960	SUPPL	2017-01-24
46089	SUPPL	2016-12-08
45979	SUPPL	2016-12-01
45971	SUPPL	2016-11-30
45272	SUPPL	2016-09-08
45210	SUPPL	2016-08-31
45190	SUPPL	2016-08-31
32430	SUPPL	2016-06-06
19473	SUPPL	2016-06-06
40300	SUPPL	2015-12-08
32429	SUPPL	2015-12-03
40299	SUPPL	2014-07-28
32428	SUPPL	2014-07-28
43435	SUPPL	2014-07-07
22923	SUPPL	2014-07-07
44431	ORIG	2014-02-04
40298	SUPPL	2013-12-20
32427	SUPPL	2013-12-20
24114	ORIG	2013-12-20
19472	SUPPL	2013-12-20
10218	SUPPL	2013-12-20
44884	ORIG	2012-12-21
43434	ORIG	2012-12-21
32426	ORIG	2012-12-19
19471	ORIG	2012-12-14