Application 215039

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIJOICE	ALPELISIB	TABLET; ORAL	50MG	No	No
002	VIJOICE	ALPELISIB	TABLET; ORAL	125MG	No	No
003	VIJOICE	ALPELISIB	TABLET; ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215039-001	VIJOICE	ALPELISIB	50MG	TABLET / ORAL	RLD	2022-04-05
N215039-002	VIJOICE	ALPELISIB	125MG	TABLET / ORAL	RLD	2022-04-05
N215039-003	VIJOICE	ALPELISIB	200MG	TABLET / ORAL	RLD, RS	2022-04-05

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03
N215039-001	8227462	2033-04-29		Drug substance, Drug product	2022-05-03
N215039-001	11433059	2037-02-17	U-4359		2025-12-22
N215039-001	12427141	2037-02-17	U-4288		2025-10-20
N215039-002	8476268	2029-09-10		Drug substance, Drug product	2022-05-03
N215039-002	8227462	2033-04-29		Drug substance, Drug product	2022-05-03
N215039-002	11433059	2037-02-17	U-4359		2025-12-22
N215039-002	12427141	2037-02-17	U-4288		2025-10-20
N215039-003	8476268	2029-09-10		Drug substance, Drug product	2022-05-03
N215039-003	8227462	2033-04-29		Drug substance, Drug product	2022-05-03
N215039-003	11433059	2037-02-17	U-4359		2025-12-22
N215039-003	12427141	2037-02-17	U-4288		2025-10-20

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215039-001	ODE-396	2029-04-05
N215039-002	ODE-396	2029-04-05
N215039-003	ODE-396	2029-04-05

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 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215039-002	VIJOICE	125MG	TABLET / ORAL	RLD	2022-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215039-003	VIJOICE	200MG	TABLET / ORAL	RLD, RS	2022-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215039-001	VIJOICE	50MG	TABLET / ORAL	RLD	2022-04-05	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-001	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-001	11433059	2037-02-17	U-4359		2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-001	12427141	2037-02-17	U-4288		2025-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	11433059	2037-02-17	U-4359		2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	12427141	2037-02-17	U-4288		2025-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	11433059	2037-02-17	U-4359		2025-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	12427141	2037-02-17	U-4288		2025-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-001	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-001	11433059	2037-02-17	U-4359		2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-001	12427141	2037-02-17	U-4288		2025-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	11433059	2037-02-17	U-4359		2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	12427141	2037-02-17	U-4288		2025-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	11433059	2037-02-17	U-4359		2025-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	12427141	2037-02-17	U-4288		2025-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-001	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-001	12427141	2037-02-17	U-4288		2025-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-002	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-002	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-002	12427141	2037-02-17	U-4288		2025-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-003	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-003	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-003	12427141	2037-02-17	U-4288		2025-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-001	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-002	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-002	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-003	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-003	8227462	2033-04-29		Drug substance, Drug product	2022-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-001	8476268	2029-09-10		Drug substance, Drug product	2022-05-03	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215039-001	ODE-396	2029-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-002	ODE-396	2029-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215039-003	ODE-396	2029-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215039-001	ODE-396	2029-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-002	ODE-396	2029-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215039-003	ODE-396	2029-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-001	ODE-396	2029-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-002	ODE-396	2029-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215039-003	ODE-396	2029-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215039-001	ODE-396	2029-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-002	ODE-396	2029-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215039-003	ODE-396	2029-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-001	ODE-396	2029-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-002	ODE-396	2029-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215039-003	ODE-396	2029-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-001	ODE-396	2029-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-002	ODE-396	2029-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215039-003	ODE-396	2029-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-001	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-001	ODE-396	2029-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-002	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-002	ODE-396	2029-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-003	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215039-003	ODE-396	2029-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-001	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-001	ODE-396	2029-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-002	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-002	ODE-396	2029-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-003	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215039-003	ODE-396	2029-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-001	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-001	ODE-396	2029-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-002	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-002	ODE-396	2029-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-003	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215039-003	ODE-396	2029-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-001	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-001	ODE-396	2029-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-002	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215039-002	ODE-396	2029-04-05	`d8e5a09893c0…`

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
VIJOICE	ALPELISIB	Novartis Pharmaceuticals Corporation	638069a4-aee0-46c9-9e21-54ad449c163c	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215039 application number: NDA215039 ndc (product): 0078-1021 ndc (product): 0078-1035 ndc (product): 0078-1028

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-1021	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1021	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1021	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1028	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1028	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1028	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1035	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1035	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1035	VIJOICE	alpelisib	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82914	SUPPL	2025-07-24
82911	SUPPL	2025-07-23
78244	SUPPL	2024-04-25
72664	ORIG	2022-11-21
72654	SUPPL	2022-11-18
72651	SUPPL	2022-11-18
70727	ORIG	2022-04-07
70710	ORIG	2022-04-06