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

NDC Listings For This Application#

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

Application 209092

Related Records#

Application Products#

NDC Listings For This Application#

Documents#