Application 207620

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENTRESTO	SACUBITRIL; VALSARTAN	TABLET;ORAL	24MG;26MG	Yes	No
002	ENTRESTO	SACUBITRIL; VALSARTAN	TABLET;ORAL	49MG;51MG	Yes	No
003	ENTRESTO	SACUBITRIL; VALSARTAN	TABLET;ORAL	97MG;103MG	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	TE codes	RLD / RS	Approval date
N207620-001	ENTRESTO	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07
N207620-002	ENTRESTO	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07
N207620-003	ENTRESTO	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N207620-001	AB
N207620-002	AB
N207620-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207620-001	9388134	2026-11-08	U-1723		2016-09-07
N207620-001	9388134*PED	2027-05-08		Pediatric extension
N207620-001	8877938	2027-05-27		Drug substance, Drug product	2015-08-06
N207620-001	8877938*PED	2027-11-27		Pediatric extension
N207620-001	11135192	2033-08-22	U-3084		2021-10-18
N207620-001	9517226	2033-08-22	U-3084		2021-03-16
N207620-001	9937143	2033-08-22	U-3084		2021-03-16
N207620-001	11058667	2036-05-09	U-3170		2021-07-13
N207620-002	9388134	2026-11-08	U-1723		2016-09-07
N207620-002	9388134*PED	2027-05-08		Pediatric extension
N207620-002	8877938	2027-05-27		Drug substance, Drug product	2015-08-06
N207620-002	8877938*PED	2027-11-27		Pediatric extension
N207620-002	11135192	2033-08-22	U-3084		2021-10-18
N207620-002	9517226	2033-08-22	U-3084		2021-03-16
N207620-002	9937143	2033-08-22	U-3084		2021-03-16
N207620-002	11058667	2036-05-09	U-3170		2021-07-13
N207620-003	9388134	2026-11-08	U-1723		2016-09-07
N207620-003	9388134*PED	2027-05-08		Pediatric extension
N207620-003	8877938	2027-05-27		Drug substance, Drug product	2015-08-06
N207620-003	8877938*PED	2027-11-27		Pediatric extension
N207620-003	11135192	2033-08-22	U-3084		2021-10-18
N207620-003	9517226	2033-08-22	U-3084		2021-03-16
N207620-003	9937143	2033-08-22	U-3084		2021-03-16
N207620-003	11058667	2036-05-09	U-3170		2021-07-13

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL	AB	RLD	2015-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-002	ENTRESTO	49MG;51MG	TABLET / ORAL	AB	RLD	2015-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-003	ENTRESTO	97MG;103MG	TABLET / ORAL	AB	RLD, RS	2015-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207620-001	ENTRESTO	24MG;26MG	TABLET / ORAL		RLD	2015-07-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207620-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207620-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207620-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207620-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207620-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207620-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207620-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-003	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207620-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 39 · 1,557 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	N207620-001	9388134	2026-11-08	U-1723		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	9388134*PED	2027-05-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	8877938	2027-05-27		Drug substance, Drug product	2015-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	8877938*PED	2027-11-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	11135192	2033-08-22	U-3084		2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	9517226	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	9937143	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-001	11058667	2036-05-09	U-3170		2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	9388134	2026-11-08	U-1723		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	9388134*PED	2027-05-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	8877938	2027-05-27		Drug substance, Drug product	2015-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	8877938*PED	2027-11-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	11135192	2033-08-22	U-3084		2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	9517226	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	9937143	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-002	11058667	2036-05-09	U-3170		2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	9388134	2026-11-08	U-1723		2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	9388134*PED	2027-05-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	8877938	2027-05-27		Drug substance, Drug product	2015-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	8877938*PED	2027-11-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	11135192	2033-08-22	U-3084		2021-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	9517226	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	9937143	2033-08-22	U-3084		2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207620-003	11058667	2036-05-09	U-3170		2021-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	8101659	2025-01-15		Drug product	2015-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	8101659*PED	2025-07-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	9388134	2026-11-08	U-1723		2016-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	9388134*PED	2027-05-08		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	8877938	2027-05-27		Drug substance, Drug product	2015-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	8877938*PED	2027-11-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	11135192	2033-08-22	U-3084		2021-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	9517226	2033-08-22	U-3084		2021-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	9937143	2033-08-22	U-3084		2021-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-001	11058667	2036-05-09	U-3170		2021-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	8101659	2025-01-15		Drug product	2015-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	8101659*PED	2025-07-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	9388134	2026-11-08	U-1723		2016-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	9388134*PED	2027-05-08		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	8877938	2027-05-27		Drug substance, Drug product	2015-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207620-002	8877938*PED	2027-11-27		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 237 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-001	M-82	2024-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-002	M-82	2024-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207620-003	M-82	2024-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-001	M-82	2024-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-002	M-82	2024-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207620-003	M-82	2024-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-001	M-82	2024-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-002	M-82	2024-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207620-003	M-82	2024-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-001	M-82	2024-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-002	M-82	2024-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207620-003	M-82	2024-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207620-001	M-82	2024-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-002	M-82	2024-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207620-003	M-82	2024-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-001	M-82	2024-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-002	M-82	2024-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207620-003	M-82	2024-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-001	M-82	2024-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-002	M-82	2024-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207620-003	M-82	2024-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-001	M-82	2024-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-002	M-82	2024-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207620-003	M-82	2024-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207620-001	M-82	2024-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207620-002	M-82	2024-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207620-003	M-82	2024-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-001	NPP	2022-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-001	PED	2023-04-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-001	M-82	2024-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-002	NPP	2022-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-002	PED	2023-04-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-002	M-82	2024-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-003	NPP	2022-10-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-003	PED	2023-04-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207620-003	M-82	2024-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207620-001	NPP	2022-10-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207620-001	PED	2023-04-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207620-001	M-82	2024-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207620-002	NPP	2022-10-01	`5d02ea3f76ae…`

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 · 4 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): 207620 application number: NDA207620 ndc (product): 0078-0777 ndc (product): 0078-0659 ndc (product): 0078-0696 ndc (product): 0078-9659 ndc (product): 0078-9777
ENTRESTO	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	152335bf-12c4-28e6-e063-6294a90ac20f	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207620 application number: NDA207620
ENTRESTO	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	14bf8041-0b7f-9acb-e063-6294a90a8256	2024-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207620 application number: NDA207620
ENTRESTO	SACUBITRIL AND VALSARTAN	Aphena Pharma Solutions - Tennessee, LLC	14bfc60a-9ddf-cac7-e063-6294a90a597b	2024-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207620 application number: NDA207620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0696	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-9659	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-9777	ENTRESTO	Sacubitril and Valsartan	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79705	SUPPL	2024-09-23
78135	SUPPL	2024-07-01
78141	SUPPL	2024-04-15
76872	SUPPL	2023-12-15
66839	SUPPL	2021-03-23
66254	SUPPL	2021-02-17
66231	SUPPL	2021-02-16
60197	SUPPL	2019-10-02
60190	SUPPL	2019-10-02
50507	SUPPL	2017-11-27
50478	SUPPL	2017-11-24
44961	ORIG	2015-08-14
23038	ORIG	2015-08-14
32858	ORIG	2015-07-07
19967	ORIG	2015-07-07
64073	ORIG	1900-01-01
64072	ORIG	1900-01-01
63193	SUPPL	1900-01-01
63192	SUPPL	1900-01-01
63191	SUPPL	1900-01-01