Application 211225

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYKADIA	CERITINIB	TABLET;ORAL	150MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211225-001	ZYKADIA	CERITINIB	150MG	TABLET / ORAL		RLD, RS	2019-03-18

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02
N211225-001	8377921	2027-11-20	U-1179		2019-08-02
N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02
N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02
N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02
N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02
N211225-001	8703787	2032-02-02	U-1179		2019-08-02
N211225-001	12357630	2037-12-13	U-3096		2025-07-28

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211225-001	ZYKADIA	150MG	TABLET / ORAL	RLD, RS	2019-03-18	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 392 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211225-001	12357630	2037-12-13	U-3096		2025-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	8377921	2027-11-20	U-1179		2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	8399450	2027-11-20		Drug substance, Drug product	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	7964592	2028-04-29		Drug substance, Drug product	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	8039479	2030-06-29		Drug substance, Drug product	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	9309229	2032-01-18		Drug substance, Drug product	2019-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211225-001	8703787	2032-02-02	U-1179		2019-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211225-001	7893074	2026-04-25		Drug substance, Drug product	2019-08-02	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211225-001	ODE*	2024-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211225-001	ODE*	2024-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211225-001	ODE*	2024-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211225-001	ODE*	2024-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211225-001	ODE*	2024-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211225-001	ODE*	2024-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211225-001	ODE*	2024-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211225-001	ODE*	2024-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211225-001	ODE*	2024-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211225-001	ODE*	2024-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211225-001	ODE*	2024-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211225-001	ODE*	2024-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211225-001	NCE	2019-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211225-001	ODE*	2024-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ODE*	2021-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211225-001	ODE*	2024-05-26	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	N211225-001	NCE	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211225-001	NCE	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211225-001	NCE	2019-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211225-001	ODE*	2024-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211225-001	ODE*	2024-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211225-001	ODE*	2024-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211225-001	ODE*	2024-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211225-001	ODE*	2024-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211225-001	ODE*	2024-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211225-001	ODE*	2024-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211225-001	ODE*	2024-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211225-001	ODE*	2024-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211225-001	ODE*	2024-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211225-001	ODE*	2024-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211225-001	ODE*	2024-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211225-001	ODE*	2024-05-26	`cb3db0bc1861…`

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
ZYKADIA	CERITINIB	Novartis Pharmaceuticals Corporation	fff5d805-4ffd-4e8e-8e63-6f129697563e	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211225 application number: NDA211225 ndc (product): 0078-0694

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0694	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68977	SUPPL	2021-10-13
68955	SUPPL	2021-10-12
68448	SUPPL	2021-08-24
68431	SUPPL	2021-08-22
58439	ORIG	2019-04-26
58040	ORIG	2019-03-19
58033	ORIG	2019-03-19