Application 218591

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENTRESTO SPRINKLE	SACUBITRIL; VALSARTAN	CAPSULE, PELLETS;ORAL	6MG;6MG	Yes	No
002	ENTRESTO SPRINKLE	SACUBITRIL; VALSARTAN	CAPSULE, PELLETS;ORAL	15MG;16MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218591-001	ENTRESTO SPRINKLE	SACUBITRIL; VALSARTAN	6MG;6MG	CAPSULE, PELLETS / ORAL		RLD	2024-04-12
N218591-002	ENTRESTO SPRINKLE	SACUBITRIL; VALSARTAN	15MG;16MG	CAPSULE, PELLETS / ORAL		RLD, RS	2024-04-12

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
N218591-001	9388134	2026-11-08	U-1723		2024-05-08
N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08
N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08
N218591-002	9388134	2026-11-08	U-1723		2024-05-08
N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08
N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08

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.

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	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218591-001	ENTRESTO SPRINKLE	6MG;6MG	CAPSULE, PELLETS / ORAL	RLD	2024-04-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218591-002	ENTRESTO SPRINKLE	15MG;16MG	CAPSULE, PELLETS / ORAL	RLD, RS	2024-04-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 116 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	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-002	9388134	2026-11-08	U-1723		2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-001	8101659	2025-01-15		Drug product	2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-002	8101659	2025-01-15		Drug product	2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-002	9388134	2026-11-08	U-1723		2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218591-001	8101659	2025-01-15		Drug product	2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-002	8101659	2025-01-15		Drug product	2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-002	9388134	2026-11-08	U-1723		2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-001	8101659	2025-01-15		Drug product	2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-002	8101659	2025-01-15		Drug product	2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-002	9388134	2026-11-08	U-1723		2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-001	8101659	2025-01-15		Drug product	2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-001	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-001	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-002	8101659	2025-01-15		Drug product	2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-002	9388134	2026-11-08	U-1723		2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-002	8877938	2027-05-27		Drug substance, Drug product	2024-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218591-002	10722471	2037-02-02	U-3896	Drug product	2024-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218591-001	8101659	2025-01-15		Drug product	2024-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218591-001	9388134	2026-11-08	U-1723		2024-05-08	`03ed91905a0d…`

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
ENTRESTO	SACUBITRIL AND VALSARTAN	Novartis Pharmaceuticals Corporation	000dc81d-ab91-450c-8eae-8eb74e72296f	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218591 application number: NDA218591

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79704	ORIG	2024-09-23
78140	ORIG	2024-07-01
78136	ORIG	2024-04-15