Application 206143

Type: NDA
Sponsor: AMGEN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CORLANOR	IVABRADINE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No
002	CORLANOR	IVABRADINE HYDROCHLORIDE	TABLET;ORAL	EQ 7.5MG BASE	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
N206143-001	CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15
N206143-002	CORLANOR	IVABRADINE HYDROCHLORIDE	EQ 7.5MG BASE	TABLET / ORAL		RLD	2015-04-15

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7361649*PED	2026-08-22		Pediatric extension
N206143-001	7361650*PED	2026-08-22		Pediatric extension
N206143-001	7879842*PED	2026-08-22		Pediatric extension
N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11
N206143-001	7867996*PED	2027-06-12		Pediatric extension
N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7361649*PED	2026-08-22		Pediatric extension
N206143-002	7361650*PED	2026-08-22		Pediatric extension
N206143-002	7879842*PED	2026-08-22		Pediatric extension
N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11
N206143-002	7867996*PED	2027-06-12		Pediatric extension

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 · 82 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	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD	2015-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2015-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL	AB	RLD, RS	2015-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206143-001	CORLANOR	EQ 5MG BASE	TABLET / ORAL		RLD	2015-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206143-002	CORLANOR	EQ 7.5MG BASE	TABLET / ORAL		RLD, RS	2015-04-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206143-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206143-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206143-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206143-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206143-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206143-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206143-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206143-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206143-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206143-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206143-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206143-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206143-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206143-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206143-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206143-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N206143-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206143-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N206143-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206143-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206143-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206143-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206143-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206143-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206143-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206143-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206143-002	AB	1	`3f0d92c62455…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 656 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	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361649*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7361650*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7879842*PED	2026-08-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206143-002	7867996*PED	2027-06-12		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361649*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7361650*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7879842*PED	2026-08-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206143-002	7867996*PED	2027-06-12		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361649	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361650	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7879842	2026-02-22	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361649*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7361650*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7879842*PED	2026-08-22		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7867996	2026-12-12	U-1694	Drug substance, Drug product	2015-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206143-001	7867996*PED	2027-06-12		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206143-001	NCE	2020-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-001	PED	2020-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	NCE	2020-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206143-002	PED	2020-10-15	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206143-001	NCE	2020-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-001	PED	2020-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-002	NCE	2020-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206143-002	PED	2020-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206143-001	NCE	2020-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-001	PED	2020-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-002	NCE	2020-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206143-002	PED	2020-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206143-001	NCE	2020-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-001	PED	2020-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-002	NCE	2020-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206143-002	PED	2020-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206143-001	NCE	2020-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-001	PED	2020-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-002	NCE	2020-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206143-002	PED	2020-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206143-001	NCE	2020-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-001	PED	2020-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-002	NCE	2020-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206143-002	PED	2020-10-15	`ea99ee380514…`

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
Corlanor	IVABRADINE	Amgen Inc	92018a65-38f6-45f7-91d4-a34921b81d0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206143 application number: NDA206143 ndc (product): 55513-800 ndc (product): 55513-810

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-800	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
55513-810	Corlanor	ivabradine	Amgen Inc	NDA	Current
70518-3309	Corlanor	ivabradine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68405	SUPPL	2021-08-18
68308	SUPPL	2021-08-06
68298	SUPPL	2021-08-05
58729	SUPPL	2019-05-15
58665	SUPPL	2019-05-14
58664	SUPPL	2019-05-13
46915	SUPPL	2017-01-19
46856	SUPPL	2017-01-19
46804	SUPPL	2017-01-11
23013	ORIG	2015-11-20
19706	ORIG	2015-04-16
10548	ORIG	2015-04-16
66845	ORIG	1900-01-01
66844	ORIG	1900-01-01
66843	ORIG	1900-01-01
66842	ORIG	1900-01-01
63927	ORIG	1900-01-01
63926	ORIG	1900-01-01