Application 215515

Type: NDA
Sponsor: ALNYLAM PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMVUTTRA	VUTRISIRAN	INJECTABLE;SUBCUTANEOUS	25MG	No	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
N215515-001	AMVUTTRA	VUTRISIRAN SODIUM	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2022-06-13

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10806791	2028-12-04		Drug substance	2022-07-13
N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31
N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13
N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215515-001	NCE	2027-06-13
N215515-001	I-964	2028-03-20
N215515-001	ODE-212	2029-06-13
N215515-001	ODE-527	2032-03-20

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	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215515-001	AMVUTTRA	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215515-001	AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-06-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 335 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	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10806791	2028-12-04		Drug substance	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	8828956	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	9370581	2028-12-04	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	8106022	2029-12-12	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10570391	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	9399775	2032-11-16	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10612024	2035-08-14	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	11401517	2035-08-14	U-3396	Drug substance, Drug product	2022-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10208307	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	10683501	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	11286486	2036-07-28	U-3396	Drug substance, Drug product	2022-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	12049628	2036-07-28	U-3396	Drug substance, Drug product	2024-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	10131907	2028-08-24	U-3396	Drug substance, Drug product	2022-07-13	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 56 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	N215515-001	NCE	2027-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	I-964	2028-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215515-001	ODE-212	2029-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	NCE	2027-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	I-964	2028-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215515-001	ODE-212	2029-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215515-001	NCE	2027-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	I-964	2028-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215515-001	ODE-212	2029-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	NCE	2027-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215515-001	ODE-212	2029-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	NCE	2027-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215515-001	ODE-212	2029-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	NCE	2027-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215515-001	ODE-212	2029-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	NCE	2027-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215515-001	ODE-212	2029-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	NCE	2027-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215515-001	ODE-212	2029-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	NCE	2027-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215515-001	ODE-212	2029-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215515-001	NCE	2027-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215515-001	ODE-212	2029-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	NCE	2027-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215515-001	ODE-212	2029-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	NCE	2027-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215515-001	ODE-212	2029-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	NCE	2027-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215515-001	ODE-212	2029-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215515-001	NCE	2027-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215515-001	ODE-212	2029-06-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	NCE	2027-06-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215515-001	ODE-212	2029-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215515-001	NCE	2027-06-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215515-001	ODE-212	2029-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215515-001	NCE	2027-06-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215515-001	ODE-212	2029-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	NCE	2027-06-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215515-001	ODE-212	2029-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215515-001	NCE	2027-06-13	`9b2671bbb829…`

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
AMVUTTRA	VUTRISIRAN	Alnylam Pharmaceuticals, Inc.	8db0facb-81b6-4006-9239-27dc6409c5d3	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215515 application number: NDA215515 ndc (product): 71336-1003

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71336-1003	AMVUTTRA	VUTRISIRAN	Alnylam Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81732	SUPPL	2025-03-26
81679	SUPPL	2025-03-24
81574	SUPPL	2025-03-14
81548	SUPPL	2025-03-13
73550	SUPPL	2023-02-17
73545	SUPPL	2023-02-17
71538	ORIG	2022-07-12
71306	ORIG	2022-06-14
71292	ORIG	2022-06-14