Application 219293

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANZITEN	NILOTINIB TARTRATE	TABLET;ORAL	EQ 71MG BASE	Yes	Yes
002	DANZITEN	NILOTINIB TARTRATE	TABLET;ORAL	EQ 95MG BASE	Yes	Yes

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
N219293-001	DANZITEN	NILOTINIB TARTRATE	EQ 71MG BASE	TABLET / ORAL		RLD, RS	2024-11-07
N219293-002	DANZITEN	NILOTINIB TARTRATE	EQ 95MG BASE	TABLET / ORAL		RLD, RS	2024-11-07

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N219293-001	10874671	2040-02-18	Drug product	2024-11-08
N219293-001	11793809	2040-02-18	Drug product	2024-11-08
N219293-001	12403140	2040-02-18	Drug product	2025-09-22
N219293-001	12629369	2040-02-18	Drug product	2026-06-05
N219293-002	10874671	2040-02-18	Drug product	2024-11-08
N219293-002	11793809	2040-02-18	Drug product	2024-11-08
N219293-002	12403140	2040-02-18	Drug product	2025-09-22
N219293-002	12629369	2040-02-18	Drug product	2026-06-05

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
2026-02-19 14:30 UTC	2026-02	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD	2024-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	DANZITEN	EQ 71MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	DANZITEN	EQ 95MG BASE	TABLET / ORAL	RLD, RS	2024-11-07	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	10874671	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	11793809	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	12403140	2040-02-18	Drug product	2025-09-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-001	12629369	2040-02-18	Drug product	2026-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	10874671	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	11793809	2040-02-18	Drug product	2024-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	12403140	2040-02-18	Drug product	2025-09-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219293-002	12629369	2040-02-18	Drug product	2026-06-05	`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
DANZITEN	NILOTINIB	Azurity Pharmaceuticals, Inc.	d288d165-3505-49bb-9b2e-124490d65f49	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219293 application number: NDA219293

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85722	SUPPL	2026-04-21
85691	SUPPL	2026-04-21
85714	SUPPL	2026-04-20
84196	SUPPL	2025-11-18
84185	SUPPL	2025-11-18
83680	ORIG	2025-10-07
80188	ORIG	2024-11-08
80184	ORIG	2024-11-08