Application 215893

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PONATINIB HYDROCHLORIDE	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	No	No
002	PONATINIB HYDROCHLORIDE	PONATINIB HYDROCHLORIDE	TABLET;ORAL	EQ 45MG BASE	No	No

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

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
A215893-001	PONATINIB HYDROCHLORIDE	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL			2023-07-14
A215893-002	PONATINIB HYDROCHLORIDE	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL			2023-07-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215893-001	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	2023-07-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215893-002	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	2023-07-14	`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
Iclusig	PONATINIB HYDROCHLORIDE	Takeda Pharmaceuticals America, Inc.	16d804b6-4957-43ee-b18c-3b36ec37c5ac	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PONATINIB HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75162	ORIG	2023-08-21
74115	ORIG	2023-04-28