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 44.

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 · 4 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
N209935-001	M-14	2029-07-01
N209935-001	PED	2030-01-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209935-001	KISQALI FEMARA CO-PACK (COPACKAGED)	2.5MG;EQ 200MG BASE	TABLET / ORAL	RLD, RS	2017-05-04	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 564 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8324225*PED	2028-12-17		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9416136*PED	2030-02-20		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8962630*PED	2030-06-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8685980*PED	2030-11-25		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8415355	2031-03-13		Drug substance, Drug product	2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	8415355*PED	2031-09-13		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9193732	2031-11-09		Drug substance, Drug product	2017-05-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9868739	2031-11-09	U-3998		2018-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9868739	2031-11-09	U-2505		2018-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9868739	2031-11-09	U-3264		2018-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9193732*PED	2032-05-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	9868739*PED	2032-05-09		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12544380	2034-08-07	U-3264		2026-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12544380	2034-08-07	U-3998		2026-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12544380*PED	2035-02-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	10799506	2036-04-14		Drug product	2020-11-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12064434	2036-04-14		Drug product	2024-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12419894	2036-04-14		Drug product	2025-10-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	10799506*PED	2036-10-14		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12064434*PED	2036-10-14		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	12419894*PED	2036-10-14		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209935-001	8324225	2028-06-17		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8324225*PED	2028-12-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-2505		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-3998		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136	2029-08-20	U-3264		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-2505		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-3998		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630	2029-12-09	U-3264		2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	9416136*PED	2030-02-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8685980	2030-05-25		Drug substance, Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	8962630*PED	2030-06-09		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N209935-001	I-951	2027-09-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	PED	2028-03-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	M-14	2029-07-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209935-001	PED	2030-01-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209935-001	I-951	2027-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	PED	2028-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	M-14	2029-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209935-001	PED	2030-01-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209935-001	I-951	2027-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209935-001	PED	2028-03-17	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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