Application 203640

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	No	No
003	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203640-001	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05
A203640-002	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05
A203640-003	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203640-001	AB
A203640-002	AB
A203640-003	AB

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 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	2024-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-002	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203640-003	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		2024-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203640-001	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2024-01-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203640-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203640-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203640-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203640-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203640-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	AB	1	`6a471c1ec25d…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203640-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203640-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203640-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A203640-003	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203640-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

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	A203640-001	PC	2025-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-002	PC	2025-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203640-003	PC	2025-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203640-001	PC	2025-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-002	PC	2025-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203640-003	PC	2025-11-19	`6a471c1ec25d…`

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
Nilotinib	NILOTINIB	Apotex Corp.	8283672c-619f-fe60-3d25-040f95ac1440	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203640 application number: ANDA203640

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77485	ORIG	2024-02-14
71678	ORIG	2022-08-01