Application 205755

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYKADIA	CERITINIB	CAPSULE;ORAL	150MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N205755-001	ZYKADIA	CERITINIB	150MG	CAPSULE / ORAL		RLD	2014-04-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13
N205755-001	8377921	2027-11-20	U-1179		2014-05-23
N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15
N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13
N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13
N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22
N205755-001	8703787	2032-02-02	U-1179		2014-05-23

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205755-001	ZYKADIA	150MG	CAPSULE / ORAL	RLD	2014-04-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 406 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205755-001	8703787	2032-02-02	U-1179		2014-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205755-001	8703787	2032-02-02	U-1179		2014-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205755-001	8703787	2032-02-02	U-1179		2014-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205755-001	8703787	2032-02-02	U-1179		2014-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	9309229	2032-01-18		Drug substance, Drug product	2016-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205755-001	8703787	2032-02-02	U-1179		2014-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	7893074	2026-04-25		Drug substance, Drug product	2014-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	8377921	2027-11-20	U-1179		2014-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	8399450	2027-11-20		Drug substance, Drug product	2017-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	7964592	2028-04-29		Drug substance, Drug product	2014-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205755-001	8039479	2030-06-29		Drug substance, Drug product	2014-05-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

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	N205755-001	ODE-145	2024-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205755-001	ODE-145	2024-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205755-001	ODE-145	2024-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205755-001	ODE-145	2024-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205755-001	ODE-145	2024-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205755-001	ODE-145	2024-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205755-001	ODE-145	2024-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205755-001	ODE-145	2024-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205755-001	ODE-145	2024-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205755-001	ODE-145	2024-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205755-001	ODE-145	2024-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205755-001	ODE-145	2024-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205755-001	NCE	2019-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205755-001	M-199	2020-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205755-001	ODE-66	2021-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205755-001	ODE-145	2024-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205755-001	ODE-145	2024-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205755-001	ODE-66	2021-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205755-001	ODE-145	2024-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205755-001	ODE-66	2021-04-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205755-001	ODE-145	2024-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205755-001	ODE-66	2021-04-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205755-001	ODE-145	2024-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205755-001	M-199	2020-05-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205755-001	ODE-66	2021-04-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205755-001	ODE-145	2024-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205755-001	M-199	2020-05-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205755-001	ODE-66	2021-04-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205755-001	ODE-145	2024-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205755-001	NCE	2019-04-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205755-001	M-199	2020-05-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205755-001	ODE-66	2021-04-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205755-001	ODE-145	2024-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205755-001	NCE	2019-04-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205755-001	M-199	2020-05-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205755-001	ODE-66	2021-04-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205755-001	ODE-145	2024-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205755-001	NCE	2019-04-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205755-001	M-199	2020-05-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205755-001	ODE-66	2021-04-29	`ea99ee380514…`

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	Name fallback brand name: ZYKADIA generic name: CERITINIB

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0640	ZYKADIA	ceritinib	Novartis Pharmaceuticals	NDA	Current
0078-0640	ZYKADIA	ceritinib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68978	SUPPL	2021-10-13
68953	SUPPL	2021-10-12
68446	SUPPL	2021-08-24
68436	SUPPL	2021-08-22
57916	SUPPL	2019-03-14
57923	SUPPL	2019-03-07
50928	SUPPL	2017-12-27
50855	SUPPL	2017-12-26
50493	SUPPL	2017-11-27
50468	SUPPL	2017-11-21
49036	SUPPL	2017-07-21
49028	SUPPL	2017-07-20
48638	SUPPL	2017-06-02
48601	SUPPL	2017-05-31
45256	SUPPL	2016-09-09
45271	SUPPL	2016-09-08
40500	SUPPL	2015-07-24
19681	SUPPL	2015-07-24
32716	SUPPL	2015-07-23
10495	SUPPL	2015-07-23
43502	ORIG	2014-05-16
24503	ORIG	2014-05-16
32715	ORIG	2014-04-30
19680	ORIG	2014-04-29