Application 214012

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEQVIO	INCLISIRAN	INJECTABLE;INJECTION	284MG/1.5ML	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214012-001	LEQVIO	INCLISIRAN SODIUM	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2021-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214012-001	8809292	2027-05-10	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	8809292	2027-05-10	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	8809292	2027-05-10	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	8222222	2027-12-29	U-4249		2022-01-18
N214012-001	8222222	2027-12-29	U-4413		2022-01-18
N214012-001	8222222	2027-12-29	U-4414		2022-01-18
N214012-001	10131907	2028-08-24	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	10131907	2028-08-24	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	10131907	2028-08-24	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	10806791	2028-12-04		Drug substance	2022-01-18
N214012-001	8828956	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	8828956	2028-12-04	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	8828956	2028-12-04	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	9370582	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	9370582	2028-12-04	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	9370582	2028-12-04	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	8106022	2029-12-12	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	8106022	2029-12-12	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	8106022	2029-12-12	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	10125369	2034-08-18	U-4249	Drug substance, Drug product	2022-01-18
N214012-001	10125369	2034-08-18	U-4413	Drug substance, Drug product	2022-01-18
N214012-001	10125369	2034-08-18	U-4414	Drug substance, Drug product	2022-01-18
N214012-001	12460206	2034-08-18		Drug substance, Drug product	2025-11-24
N214012-001	10851377	2036-08-25	U-4249		2022-01-18
N214012-001	10851377	2036-08-25	U-4413		2022-01-18
N214012-001	10851377	2036-08-25	U-4414		2022-01-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214012-001	NCE	2026-12-22
N214012-001	I-985	2029-02-12
N214012-001	NPP	2029-02-12

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	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214012-001	LEQVIO	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-12-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 489 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	N214012-001	8809292	2027-05-10	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	8222222	2027-12-29	U-4249		2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	10131907	2028-08-24	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	10806791	2028-12-04		Drug substance	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	8828956	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	9370582	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	8106022	2029-12-12	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	10125369	2034-08-18	U-4249	Drug substance, Drug product	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	12460206	2034-08-18		Drug substance, Drug product	2025-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214012-001	10851377	2036-08-25	U-4249		2022-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	8809292	2027-05-10	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	8222222	2027-12-29	U-4249		2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	10131907	2028-08-24	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	10806791	2028-12-04		Drug substance	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	8828956	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	9370582	2028-12-04	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	8106022	2029-12-12	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	10125369	2034-08-18	U-4249	Drug substance, Drug product	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	12460206	2034-08-18		Drug substance, Drug product	2025-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	10851377	2036-08-25	U-4249		2022-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214012-001	8809292	2027-05-10	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	8222222	2027-12-29	U-3652		2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	10131907	2028-08-24	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	10806791	2028-12-04		Drug substance	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	8828956	2028-12-04	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	9370582	2028-12-04	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	8106022	2029-12-12	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	10125369	2034-08-18	U-3652	Drug substance, Drug product	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214012-001	10851377	2036-08-25	U-3652		2022-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	8809292	2027-05-10	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	8222222	2027-12-29	U-3652		2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	10131907	2028-08-24	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	10806791	2028-12-04		Drug substance	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	8828956	2028-12-04	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	9370582	2028-12-04	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	8106022	2029-12-12	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	10125369	2034-08-18	U-3652	Drug substance, Drug product	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	10851377	2036-08-25	U-3652		2022-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214012-001	8809292	2027-05-10	U-3652	Drug substance, Drug product	2022-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214012-001	8222222	2027-12-29	U-3652		2022-01-18	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214012-001	NCE	2026-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214012-001	NCE	2026-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214012-001	NCE	2026-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214012-001	NCE	2026-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214012-001	NCE	2026-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214012-001	NCE	2026-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214012-001	NCE	2026-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214012-001	NCE	2026-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214012-001	NCE	2026-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214012-001	NCE	2026-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214012-001	NCE	2026-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214012-001	NCE	2026-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214012-001	NCE	2026-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214012-001	NCE	2026-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214012-001	NCE	2026-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214012-001	NCE	2026-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214012-001	NCE	2026-12-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214012-001	NCE	2026-12-22	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214012-001	NCE	2026-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214012-001	NCE	2026-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214012-001	NCE	2026-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214012-001	NCE	2026-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214012-001	NCE	2026-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214012-001	NCE	2026-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214012-001	NCE	2026-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214012-001	NCE	2026-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214012-001	NCE	2026-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214012-001	NCE	2026-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214012-001	NCE	2026-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214012-001	NCE	2026-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214012-001	NCE	2026-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214012-001	NCE	2026-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214012-001	I-985	2029-02-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214012-001	NPP	2029-02-12	`a50c72e98297…`

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
LEQVIO	INCLISIRAN	Novartis Pharmaceuticals Corporation	6fc0afca-4513-4c35-b594-6544aee29a44	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214012 application number: NDA214012 ndc (product): 0078-1000

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-1000	LEQVIO	inclisiran	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1000	LEQVIO	inclisiran	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1000	LEQVIO	inclisiran	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85071	SUPPL	2026-02-18
85070	SUPPL	2026-02-18
85043	SUPPL	2026-02-13
85042	SUPPL	2026-02-13
83025	SUPPL	2025-08-01
83020	SUPPL	2025-08-01
78748	SUPPL	2024-06-10
78744	SUPPL	2024-06-07
76737	SUPPL	2023-12-05
74721	SUPPL	2023-07-11
74713	SUPPL	2023-07-10
73594	SUPPL	2023-02-22
73568	SUPPL	2023-02-21
71264	SUPPL	2022-06-10
71233	SUPPL	2022-06-07
69936	ORIG	2022-01-20
69751	ORIG	2021-12-23
69748	ORIG	2021-12-23