Application 212194

Type: NDA
Sponsor: ALNYLAM PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GIVLAARI	GIVOSIRAN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	Yes	Yes

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
N212194-001	GIVLAARI	GIVOSIRAN SODIUM	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2019-11-20

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	9631193	2033-03-15	U-2672		2019-12-12
N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12
N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212194-001	ODE-273	2026-11-20

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	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212194-001	GIVLAARI	EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-11-20	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 439 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	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9631193	2033-03-15	U-2672		2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	9133461	2033-11-30	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	10119143	2034-10-03	U-2672	Drug substance, Drug product	2019-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	11028392	2034-10-03	U-2672	Drug substance, Drug product	2022-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	9150605	2025-08-28		Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	10131907	2028-08-24	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	8828956	2028-12-04	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	8106022	2029-12-12	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	10125364	2033-03-15	U-2672	Drug substance, Drug product	2019-12-12	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 69 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	N212194-001	ODE-273	2026-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212194-001	ODE-273	2026-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212194-001	ODE-273	2026-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212194-001	ODE-273	2026-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212194-001	ODE-273	2026-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	NCE	2024-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212194-001	ODE-273	2026-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	NCE	2024-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212194-001	ODE-273	2026-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	NCE	2024-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212194-001	ODE-273	2026-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	NCE	2024-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212194-001	ODE-273	2026-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212194-001	NCE	2024-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212194-001	ODE-273	2026-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	NCE	2024-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212194-001	ODE-273	2026-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	NCE	2024-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212194-001	ODE-273	2026-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	NCE	2024-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212194-001	ODE-273	2026-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212194-001	NCE	2024-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212194-001	ODE-273	2026-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	NCE	2024-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212194-001	ODE-273	2026-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212194-001	NCE	2024-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212194-001	ODE-273	2026-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212194-001	NCE	2024-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212194-001	ODE-273	2026-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212194-001	NCE	2024-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212194-001	ODE-273	2026-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212194-001	NCE	2024-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212194-001	ODE-273	2026-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	NCE	2024-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212194-001	ODE-273	2026-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212194-001	NCE	2024-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212194-001	ODE-273	2026-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212194-001	NCE	2024-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212194-001	ODE-273	2026-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212194-001	NCE	2024-11-20	`c0c555d07b60…`

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
GIVLAARI	GIVOSIRAN SODIUM	Alnylam Pharmaceuticals, Inc.	167e663c-11e1-497b-a3fc-951d65d58eaa	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212194 application number: NDA212194 ndc (product): 71336-1001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71336-1001	GIVLAARI	givosiran sodium	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1001	GIVLAARI	givosiran sodium	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1001	GIVLAARI	givosiran sodium	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1001	GIVLAARI	givosiran sodium	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1001	GIVLAARI	givosiran sodium	Alnylam Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78320	SUPPL	2024-04-30
78307	SUPPL	2024-04-30
73497	SUPPL	2023-02-14
73472	SUPPL	2023-02-13
69176	SUPPL	2021-10-29
69154	SUPPL	2021-10-29
61248	ORIG	2019-12-12
61018	ORIG	2019-11-22
60994	ORIG	2019-11-20