Application 212526

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIQRAY	ALPELISIB	TABLET;ORAL	50MG	Yes	No
002	PIQRAY	ALPELISIB	TABLET;ORAL	150MG	Yes	No
003	PIQRAY	ALPELISIB	TABLET;ORAL	200MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0701	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0708	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0715	PIQRAY	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77246	SUPPL	2024-01-19
77244	SUPPL	2024-01-19
72714	SUPPL	2022-11-25
72680	SUPPL	2022-11-23
71018	SUPPL	2022-05-06
71001	SUPPL	2022-05-05
68162	SUPPL	2021-07-22
68152	SUPPL	2021-07-21
64497	SUPPL	2020-09-04
64477	SUPPL	2020-09-02
59111	ORIG	2019-06-18
59093	ORIG	2019-06-17
58863	ORIG	2019-05-24

Application 212526

Related Records#

Application Products#

NDC Listings For This Application#

Documents#