Application 022068

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TASIGNA	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG BASE	Yes	Yes
002	TASIGNA	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	Yes	No
003	TASIGNA	NILOTINIB HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022068-001	TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, RS	2007-10-29
N022068-002	TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2010-06-17
N022068-003	TASIGNA	NILOTINIB HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	2018-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022068-001	AB
N022068-002	AB
N022068-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022068-001	8389537	2026-07-18	U-1374		2013-03-29
N022068-001	8415363	2026-07-18	U-1374	Drug substance, Drug product	2013-06-13
N022068-001	8415363	2026-07-18	U-1407	Drug substance, Drug product	2013-06-13
N022068-001	8501760	2026-07-18		Drug product	2013-08-09
N022068-001	8389537*PED	2027-01-18		Pediatric extension
N022068-001	8415363*PED	2027-01-18		Pediatric extension
N022068-001	8501760*PED	2027-01-18		Pediatric extension
N022068-001	8293756	2027-09-25		Drug product	2014-10-08
N022068-001	8293756*PED	2028-03-25		Pediatric extension
N022068-001	8163904	2028-08-23		Drug substance, Drug product	2012-05-10
N022068-001	8163904*PED	2029-02-23		Pediatric extension
N022068-001	9061029	2032-04-07	U-1374	Drug substance	2016-12-01
N022068-001	9061029	2032-04-07	U-3231	Drug substance	2016-12-01
N022068-001	9061029*PED	2032-10-07		Pediatric extension
N022068-002	8389537	2026-07-18	U-1374
N022068-002	8415363	2026-07-18	U-1374	Drug substance, Drug product
N022068-002	8415363	2026-07-18	U-1407	Drug substance, Drug product
N022068-002	8501760	2026-07-18		Drug product	2013-08-09
N022068-002	8389537*PED	2027-01-18		Pediatric extension
N022068-002	8415363*PED	2027-01-18		Pediatric extension
N022068-002	8501760*PED	2027-01-18		Pediatric extension
N022068-002	8293756	2027-09-25		Drug product	2014-10-08
N022068-002	8293756*PED	2028-03-25		Pediatric extension
N022068-002	8163904	2028-08-23		Drug substance, Drug product
N022068-002	8163904*PED	2029-02-23		Pediatric extension
N022068-002	9061029	2032-04-07	U-1374	Drug substance	2016-12-01
N022068-002	9061029	2032-04-07	U-3231	Drug substance	2016-12-01
N022068-002	9061029*PED	2032-10-07		Pediatric extension
N022068-003	8389537	2026-07-18	U-1374		2018-04-12
N022068-003	8415363	2026-07-18	U-1374	Drug substance, Drug product	2018-04-12
N022068-003	8415363	2026-07-18	U-1407	Drug substance, Drug product	2018-04-12
N022068-003	8501760	2026-07-18		Drug product	2018-04-12
N022068-003	8389537*PED	2027-01-18		Pediatric extension
N022068-003	8415363*PED	2027-01-18		Pediatric extension
N022068-003	8501760*PED	2027-01-18		Pediatric extension
N022068-003	8293756	2027-09-25		Drug product	2018-04-12
N022068-003	8293756*PED	2028-03-25		Pediatric extension
N022068-003	8163904	2028-08-23		Drug substance, Drug product	2018-04-12
N022068-003	8163904*PED	2029-02-23		Pediatric extension
N022068-003	9061029	2032-04-07	U-1374	Drug substance	2018-04-12
N022068-003	9061029	2032-04-07	U-3231	Drug substance	2018-04-12
N022068-003	9061029*PED	2032-10-07		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022068-001	ODE-380	2028-09-23
N022068-001	PED	2029-03-23
N022068-002	ODE-380	2028-09-23
N022068-002	PED	2029-03-23
N022068-003	ODE-380	2028-09-23
N022068-003	PED	2029-03-23

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022068-001	TASIGNA	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, RS	2007-10-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	TASIGNA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD	2010-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	TASIGNA	EQ 50MG BASE	CAPSULE / ORAL	AB	RLD	2018-03-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022068-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022068-001	8389537	2026-07-18	U-1374		2013-03-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8415363	2026-07-18	U-1407	Drug substance, Drug product	2013-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8415363	2026-07-18	U-1374	Drug substance, Drug product	2013-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8501760	2026-07-18		Drug product	2013-08-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8389537*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8415363*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8501760*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8293756	2027-09-25		Drug product	2014-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8293756*PED	2028-03-25		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8163904	2028-08-23		Drug substance, Drug product	2012-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	8163904*PED	2029-02-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	9061029	2032-04-07	U-1374	Drug substance	2016-12-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	9061029	2032-04-07	U-3231	Drug substance	2016-12-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	9061029*PED	2032-10-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8389537	2026-07-18	U-1374			`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8415363	2026-07-18	U-1407	Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8415363	2026-07-18	U-1374	Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8501760	2026-07-18		Drug product	2013-08-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8389537*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8415363*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8501760*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8293756	2027-09-25		Drug product	2014-10-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8293756*PED	2028-03-25		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8163904	2028-08-23		Drug substance, Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	8163904*PED	2029-02-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	9061029	2032-04-07	U-1374	Drug substance	2016-12-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	9061029	2032-04-07	U-3231	Drug substance	2016-12-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	9061029*PED	2032-10-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8389537	2026-07-18	U-1374		2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8415363	2026-07-18	U-1407	Drug substance, Drug product	2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8415363	2026-07-18	U-1374	Drug substance, Drug product	2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8501760	2026-07-18		Drug product	2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8389537*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8415363*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8501760*PED	2027-01-18		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8293756	2027-09-25		Drug product	2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8293756*PED	2028-03-25		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8163904	2028-08-23		Drug substance, Drug product	2018-04-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	8163904*PED	2029-02-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	9061029	2032-04-07	U-1374	Drug substance	2018-04-12	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N022068-001	ODE-380	2028-09-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-001	PED	2029-03-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	ODE-380	2028-09-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-002	PED	2029-03-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	ODE-380	2028-09-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022068-003	PED	2029-03-23	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Tasigna	NILOTINIB	Novartis Pharmaceuticals Corporation	6093952a-5248-45cb-ad17-33716a411146	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022068 application number: NDA022068 ndc (product): 0078-0592 ndc (product): 0078-0526 ndc (product): 0078-0951

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0526	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0592	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0951	Tasigna	nilotinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79462	SUPPL	2024-08-22
79458	SUPPL	2024-08-22
77699	SUPPL	2024-03-04
77698	SUPPL	2024-03-04
77686	SUPPL	2024-03-01
77462	SUPPL	2024-02-12
77447	SUPPL	2024-02-09
75659	SUPPL	2023-10-03
75647	SUPPL	2023-10-03
68787	SUPPL	2021-09-27
68786	SUPPL	2021-09-27
68777	SUPPL	2021-09-24
68776	SUPPL	2021-09-24
68775	SUPPL	2021-09-24
65558	SUPPL	2020-12-10
65557	SUPPL	2020-12-10
65539	SUPPL	2020-12-09
60128	SUPPL	2019-09-26
60127	SUPPL	2019-09-26
60113	SUPPL	2019-09-26
55317	SUPPL	2018-08-24
55268	SUPPL	2018-08-22
53086	SUPPL	2018-03-22
53144	SUPPL	2018-03-21
50965	SUPPL	2017-12-29
50847	SUPPL	2017-12-22
47334	SUPPL	2017-02-27
47297	SUPPL	2017-02-23
45423	SUPPL	2016-09-30
45424	SUPPL	2016-09-28
38187	SUPPL	2015-10-22
6820	SUPPL	2015-10-16
38186	SUPPL	2015-01-30
6819	SUPPL	2015-01-28
38185	SUPPL	2014-09-30
29200	SUPPL	2014-09-29
29198	SUPPL	2014-01-23
16891	SUPPL	2014-01-23
38184	SUPPL	2013-10-01
29199	SUPPL	2013-10-01
38183	SUPPL	2013-06-18
29196	SUPPL	2013-06-13
29197	SUPPL	2013-05-28
29195	SUPPL	2013-05-22
6818	SUPPL	2012-12-26
16890	SUPPL	2012-12-21
29194	SUPPL	2012-05-03
38182	SUPPL	2012-05-02
38181	SUPPL	2011-11-25
16889	SUPPL	2011-11-25
29193	SUPPL	2011-11-22
29192	SUPPL	2011-11-22
29191	SUPPL	2011-11-01
16888	SUPPL	2011-11-01
29190	SUPPL	2011-01-20
38180	SUPPL	2011-01-14
29189	SUPPL	2010-06-22
6817	SUPPL	2010-06-22
38179	SUPPL	2010-06-17
16887	SUPPL	2010-06-17
6815	SUPPL	2010-03-18
16885	SUPPL	2010-03-17
6816	SUPPL	2010-01-21
16886	SUPPL	2009-09-16
44674	ORIG	2008-07-22
21924	ORIG	2008-03-14
6814	ORIG	2007-11-08
16884	ORIG	2007-10-29
64025	ORIG	1900-01-01
64024	ORIG	1900-01-01
64023	ORIG	1900-01-01
64022	ORIG	1900-01-01
63181	SUPPL	1900-01-01
63180	SUPPL	1900-01-01
63179	SUPPL	1900-01-01