Application 209935

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KISQALI FEMARA CO-PACK (COPACKAGED)	LETROZOLE; RIBOCICLIB SUCCINATE	TABLET, TABLET;ORAL	2.5MG,N/A;N/A,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
N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	LETROZOLE; RIBOCICLIB SUCCINATE	2.5MG;EQ 200MG BASE	TABLET / ORAL		RLD, RS	2017-05-04

Orange Book patents#

Current patent rows page 1 of 1 · 29 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19
N209935-001	8324225*PED	2028-12-17		Pediatric extension
N209935-001	9416136	2029-08-20	U-2505		2017-05-19
N209935-001	9416136	2029-08-20	U-3264		2017-05-19
N209935-001	9416136	2029-08-20	U-3998		2017-05-19
N209935-001	8962630	2029-12-09	U-2505		2017-05-19
N209935-001	8962630	2029-12-09	U-3264		2017-05-19
N209935-001	8962630	2029-12-09	U-3998		2017-05-19
N209935-001	9416136*PED	2030-02-20		Pediatric extension
N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19
N209935-001	8962630*PED	2030-06-09		Pediatric extension
N209935-001	8685980*PED	2030-11-25		Pediatric extension
N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19
N209935-001	8415355*PED	2031-09-13		Pediatric extension
N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19
N209935-001	9868739	2031-11-09	U-2505		2018-06-05
N209935-001	9868739	2031-11-09	U-3264		2018-06-05
N209935-001	9868739	2031-11-09	U-3998		2018-06-05
N209935-001	9193732*PED	2032-05-09		Pediatric extension
N209935-001	9868739*PED	2032-05-09		Pediatric extension
N209935-001	12544380	2034-08-07	U-3264		2026-02-10
N209935-001	12544380	2034-08-07	U-3998		2026-02-10
N209935-001	12544380*PED	2035-02-07		Pediatric extension
N209935-001	10799506	2036-04-14		Drug product	2020-11-06
N209935-001	12064434	2036-04-14		Drug product	2024-09-13
N209935-001	12419894	2036-04-14		Drug product	2025-10-02
N209935-001	10799506*PED	2036-10-14		Pediatric extension
N209935-001	12064434*PED	2036-10-14		Pediatric extension
N209935-001	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
N209935-001	I-951	2027-09-17
N209935-001	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	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG,N/A;N/A,EQ 200MG BASE	TABLET, TABLET / ORAL	RLD, RS	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 477 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	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12544380	2034-08-07	U-3264		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12544380	2034-08-07	U-3998		2026-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 55 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	N209935-001	I-951	2027-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209935-001	I-951	2027-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209935-001	I-951	2027-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209935-001	I-951	2027-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209935-001	I-951	2027-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	NPP	2024-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209935-001	I-951	2027-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	NPP	2024-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209935-001	I-951	2027-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209935-001	NPP	2024-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	NPP	2024-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209935-001	I-951	2027-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209935-001	NPP	2024-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209935-001	I-951	2027-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209935-001	NPP	2024-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209935-001	NPP	2024-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209935-001	NPP	2024-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209935-001	NPP	2024-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	NCE	2022-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209935-001	NPP	2024-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209935-001	NCE	2022-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209935-001	NPP	2024-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209935-001	NCE	2022-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209935-001	NPP	2024-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209935-001	NCE	2022-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209935-001	NCE	2022-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209935-001	NPP	2024-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209935-001	NCE	2022-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209935-001	NCE	2022-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209935-001	NCE	2022-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209935-001	NCE	2022-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209935-001	NCE	2022-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209935-001	NCE	2022-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209935-001	NCE	2022-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209935-001	NCE	2022-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209935-001	NPP	2024-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209935-001	NPP	2024-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209935-001	NPP	2024-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209935-001	NPP	2024-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209935-001	NPP	2024-12-10	`9b2671bbb829…`

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 FEMARA CO-PACK	LETROZOLE AND RIBOCICLIB	Novartis Pharmaceuticals Corporation	aa5e4446-19cd-4235-a382-5b48bf6c3b2f	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209935 application number: NDA209935 ndc (product): 0078-0916 ndc (product): 0078-0909 ndc (product): 0078-0923

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0909	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0916	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0923	KISQALI FEMARA CO-PACK	letrozole and ribociclib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84363	SUPPL	2025-12-08
84345	SUPPL	2025-12-01
82979	SUPPL	2025-07-29
82970	SUPPL	2025-07-29
81285	SUPPL	2025-02-19
81226	SUPPL	2025-02-12
80224	SUPPL	2024-11-20
79999	SUPPL	2024-10-25
79892	SUPPL	2024-10-15
79886	SUPPL	2024-10-15
79657	SUPPL	2024-09-19
75306	SUPPL	2023-08-29
75295	SUPPL	2023-08-25
72264	SUPPL	2022-10-07
72238	SUPPL	2022-10-04
71141	SUPPL	2022-05-25
71140	SUPPL	2022-05-25
69592	SUPPL	2021-12-16
69530	SUPPL	2021-12-13
68645	SUPPL	2021-09-20
68632	SUPPL	2021-09-17
63816	SUPPL	2020-07-07
63814	SUPPL	2020-07-07
61617	SUPPL	2020-01-22
61613	SUPPL	2020-01-22
59976	SUPPL	2019-09-11
59969	SUPPL	2019-09-11
57606	SUPPL	2019-02-14
57591	SUPPL	2019-02-14
53815	SUPPL	2018-04-24
53798	SUPPL	2018-04-24
49520	ORIG	2017-08-23
48296	ORIG	2017-05-09
48246	ORIG	2017-05-05