Application 209092

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KISQALI	RIBOCICLIB SUCCINATE	TABLET;ORAL	EQ 200MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209092-001	KISQALI	RIBOCICLIB SUCCINATE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2017-03-13

Orange Book patents#

Current patent rows page 1 of 1 · 43 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209092-001	8324225	2028-06-17		Drug substance, Drug product	2017-04-03
N209092-001	8324225*PED	2028-12-17		Pediatric extension
N209092-001	9416136	2029-08-20	U-1981		2017-04-03
N209092-001	9416136	2029-08-20	U-2355		2017-04-03
N209092-001	9416136	2029-08-20	U-2356		2017-04-03
N209092-001	9416136	2029-08-20	U-3265		2017-04-03
N209092-001	9416136	2029-08-20	U-3266		2017-04-03
N209092-001	9416136	2029-08-20	U-3975		2017-04-03
N209092-001	9416136	2029-08-20	U-3999		2017-04-03
N209092-001	8962630	2029-12-09	U-1981		2017-04-03
N209092-001	8962630	2029-12-09	U-2355		2017-04-03
N209092-001	8962630	2029-12-09	U-2356		2017-04-03
N209092-001	8962630	2029-12-09	U-3265		2017-04-03
N209092-001	8962630	2029-12-09	U-3266		2017-04-03
N209092-001	8962630	2029-12-09	U-3975		2017-04-03
N209092-001	8962630	2029-12-09	U-3999		2017-04-03
N209092-001	9416136*PED	2030-02-20		Pediatric extension
N209092-001	8685980	2030-05-25		Drug substance, Drug product	2017-04-03
N209092-001	8962630*PED	2030-06-09		Pediatric extension
N209092-001	8685980*PED	2030-11-25		Pediatric extension
N209092-001	8415355	2031-03-13		Drug substance, Drug product	2017-04-03
N209092-001	8415355*PED	2031-09-13		Pediatric extension
N209092-001	9193732	2031-11-09		Drug substance, Drug product	2017-04-03
N209092-001	9868739	2031-11-09	U-1981		2018-06-05
N209092-001	9868739	2031-11-09	U-2355		2018-06-05
N209092-001	9868739	2031-11-09	U-2356		2018-06-05
N209092-001	9868739	2031-11-09	U-3265		2018-06-05
N209092-001	9868739	2031-11-09	U-3266		2018-06-05
N209092-001	9868739	2031-11-09	U-3975		2018-06-05
N209092-001	9868739	2031-11-09	U-3999		2018-06-05
N209092-001	9193732*PED	2032-05-09		Pediatric extension
N209092-001	9868739*PED	2032-05-09		Pediatric extension
N209092-001	12544379	2034-08-07	U-3975		2026-02-10
N209092-001	12544380	2034-08-07	U-4404		2026-02-10
N209092-001	12544380	2034-08-07	U-4405		2026-02-10
N209092-001	12544379*PED	2035-02-07		Pediatric extension
N209092-001	12544380*PED	2035-02-07		Pediatric extension
N209092-001	10799506	2036-04-14		Drug product	2020-11-06
N209092-001	12064434	2036-04-14		Drug product	2024-09-13
N209092-001	12419894	2036-04-14		Drug product	2025-10-02
N209092-001	10799506*PED	2036-10-14		Pediatric extension
N209092-001	12064434*PED	2036-10-14		Pediatric extension
N209092-001	12419894*PED	2036-10-14		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209092-001	I-950	2027-09-17
N209092-001	PED	2028-03-17

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209092-001	KISQALI	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-03-13	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 855 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209092-001	8324225	2028-06-17		Drug substance, Drug product	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-2355		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-2356		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-1981		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-3999		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-3266		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-3265		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9416136	2029-08-20	U-3975		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-1981		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-2356		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-2355		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-3999		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-3265		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-3266		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8962630	2029-12-09	U-3975		2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8685980	2030-05-25		Drug substance, Drug product	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	8415355	2031-03-13		Drug substance, Drug product	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9193732	2031-11-09		Drug substance, Drug product	2017-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-2355		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-2356		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-3999		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-1981		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-3975		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-3265		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	9868739	2031-11-09	U-3266		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	12544379	2034-08-07	U-3975		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	12544380	2034-08-07	U-4404		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	12544380	2034-08-07	U-4405		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	10799506	2036-04-14		Drug product	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	12064434	2036-04-14		Drug product	2024-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209092-001	12419894	2036-04-14		Drug product	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	8324225	2028-06-17		Drug substance, Drug product	2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-2355		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-2356		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-1981		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-3999		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-3266		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-3265		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	9416136	2029-08-20	U-3975		2017-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	8962630	2029-12-09	U-1981		2017-04-03	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209092-001	I-950	2027-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209092-001	I-950	2027-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209092-001	I-950	2027-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209092-001	I-950	2027-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209092-001	I-950	2027-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209092-001	NPP	2024-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209092-001	I-950	2027-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209092-001	NPP	2024-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209092-001	I-950	2027-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209092-001	NPP	2024-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209092-001	NPP	2024-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209092-001	I-950	2027-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209092-001	NPP	2024-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209092-001	I-950	2027-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209092-001	NPP	2024-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209092-001	NPP	2024-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209092-001	NPP	2024-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209092-001	NPP	2024-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209092-001	NCE	2022-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209092-001	NPP	2024-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209092-001	NCE	2022-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209092-001	NPP	2024-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209092-001	NCE	2022-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209092-001	NPP	2024-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209092-001	I-783	2021-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209092-001	I-784	2021-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209092-001	NCE	2022-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209092-001	NCE	2022-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209092-001	NPP	2024-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209092-001	I-783	2021-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209092-001	I-784	2021-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209092-001	NCE	2022-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209092-001	I-783	2021-07-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209092-001	I-784	2021-07-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209092-001	NCE	2022-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209092-001	I-783	2021-07-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209092-001	I-784	2021-07-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209092-001	NCE	2022-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209092-001	I-783	2021-07-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209092-001	I-784	2021-07-18	`8869cabd3fbd…`

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
KISQALI	RIBOCICLIB	Novartis Pharmaceuticals Corporation	aaeaef94-f3f5-4367-8ea2-b181d7be2da8	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209092 application number: NDA209092 ndc (product): 0078-0860 ndc (product): 0078-0867 ndc (product): 0078-0874

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0860	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0867	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0874	KISQALI	ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84362	SUPPL	2025-12-08
84344	SUPPL	2025-12-01
82978	SUPPL	2025-07-29
82971	SUPPL	2025-07-29
81286	SUPPL	2025-02-19
81225	SUPPL	2025-02-12
80223	SUPPL	2024-11-20
79998	SUPPL	2024-10-25
79891	SUPPL	2024-10-15
79885	SUPPL	2024-10-15
79656	SUPPL	2024-09-19
79159	SUPPL	2024-07-24
79151	SUPPL	2024-07-23
75307	SUPPL	2023-08-29
75298	SUPPL	2023-08-28
72263	SUPPL	2022-10-07
72237	SUPPL	2022-10-04
69591	SUPPL	2021-12-16
69529	SUPPL	2021-12-13
68644	SUPPL	2021-09-20
68631	SUPPL	2021-09-17
63815	SUPPL	2020-07-07
63813	SUPPL	2020-07-07
61616	SUPPL	2020-01-22
61612	SUPPL	2020-01-22
59973	SUPPL	2019-09-11
59968	SUPPL	2019-09-11
56321	SUPPL	2019-06-03
55355	SUPPL	2018-08-29
54954	SUPPL	2018-07-24
47732	ORIG	2017-03-28
47530	ORIG	2017-03-13
47529	ORIG	2017-03-13