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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N212526-001	PIQRAY	ALPELISIB	50MG	TABLET / ORAL	RLD	2019-05-24
N212526-002	PIQRAY	ALPELISIB	150MG	TABLET / ORAL	RLD	2019-05-24
N212526-003	PIQRAY	ALPELISIB	200MG	TABLET / ORAL	RLD, RS	2019-05-24

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17
N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17
N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17
N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212526-001	I-937	2027-01-18
N212526-002	I-937	2027-01-18
N212526-003	I-937	2027-01-18

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 4 · 123 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	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-002	PIQRAY	150MG	TABLET / ORAL	RLD	2019-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212526-003	PIQRAY	200MG	TABLET / ORAL	RLD, RS	2019-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212526-001	PIQRAY	50MG	TABLET / ORAL	RLD	2019-05-24	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 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	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	8476268	2029-09-10		Drug substance, Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	8227462	2033-04-29	U-3809	Drug substance, Drug product	2019-06-17	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 150 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	N212526-001	I-937	2027-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-002	I-937	2027-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212526-003	I-937	2027-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-001	I-937	2027-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-002	I-937	2027-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212526-003	I-937	2027-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212526-001	I-937	2027-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-002	I-937	2027-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212526-003	I-937	2027-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-001	I-937	2027-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-002	I-937	2027-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212526-003	I-937	2027-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-001	I-937	2027-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-002	I-937	2027-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212526-003	I-937	2027-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-001	I-937	2027-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-002	I-937	2027-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	NCE	2024-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212526-003	I-937	2027-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-001	I-937	2027-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-002	I-937	2027-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	NCE	2024-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212526-003	I-937	2027-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-001	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-002	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	NCE	2024-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212526-003	I-937	2027-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-001	I-937	2027-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-002	I-937	2027-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	NCE	2024-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212526-003	I-937	2027-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212526-001	NCE	2024-05-24	`d06236e962d9…`

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
PIQRAY	ALPELISIB	Novartis Pharmaceuticals Corporation	b20b4e18-7a4b-4500-a08f-06c6dab0ee5b	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212526 application number: NDA212526 ndc (product): 0078-0715 ndc (product): 0078-0708 ndc (product): 0078-0701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

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