Application 214103

Type: NDA
Sponsor: ALNYLAM PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXLUMO	LUMASIRAN	SOLUTION;SUBCUTANEOUS	94.5MG/0.5ML	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
N214103-001	OXLUMO	LUMASIRAN SODIUM	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2020-11-23

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214103-001	10131907	2028-08-24	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	8828956	2028-12-04	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	8106022	2029-12-12	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	10435692	2034-12-26	U-2995		2020-12-10
N214103-001	10465195	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	10487330	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	11060093	2034-12-26	U-2995	Drug substance, Drug product	2021-08-17
N214103-001	9828606	2034-12-26		Drug substance, Drug product	2020-12-10
N214103-001	10612024	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	10612027	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	11401517	2035-08-14	U-2995	Drug substance, Drug product	2022-09-19
N214103-001	10478500	2035-10-09	U-2995	Drug substance, Drug product	2020-12-10
N214103-001	11446380	2035-10-09		Drug substance, Drug product	2022-10-19
N214103-001	11261447	2038-11-20	U-2995	Drug substance, Drug product	2022-03-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214103-001	ODE-339	2027-11-23
N214103-001	ODE-415	2029-10-06

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	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214103-001	OXLUMO	EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214103-001	OXLUMO	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2020-11-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 464 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	N214103-001	10131907	2028-08-24	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	8828956	2028-12-04	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	8106022	2029-12-12	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10435692	2034-12-26	U-2995		2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10465195	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10487330	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	11060093	2034-12-26	U-2995	Drug substance, Drug product	2021-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	9828606	2034-12-26		Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10612024	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10612027	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	11401517	2035-08-14	U-2995	Drug substance, Drug product	2022-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	10478500	2035-10-09	U-2995	Drug substance, Drug product	2020-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	11446380	2035-10-09		Drug substance, Drug product	2022-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	11261447	2038-11-20	U-2995	Drug substance, Drug product	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10131907	2028-08-24	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	8828956	2028-12-04	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	8106022	2029-12-12	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10435692	2034-12-26	U-2995		2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10465195	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10487330	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	11060093	2034-12-26	U-2995	Drug substance, Drug product	2021-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	9828606	2034-12-26		Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10612024	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10612027	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	11401517	2035-08-14	U-2995	Drug substance, Drug product	2022-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	10478500	2035-10-09	U-2995	Drug substance, Drug product	2020-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	11446380	2035-10-09		Drug substance, Drug product	2022-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	11261447	2038-11-20	U-2995	Drug substance, Drug product	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10131907	2028-08-24	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	8828956	2028-12-04	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	8106022	2029-12-12	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10435692	2034-12-26	U-2995		2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10465195	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10487330	2034-12-26	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	11060093	2034-12-26	U-2995	Drug substance, Drug product	2021-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	9828606	2034-12-26		Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10612024	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10612027	2035-08-14	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	11401517	2035-08-14	U-2995	Drug substance, Drug product	2022-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	10478500	2035-10-09	U-2995	Drug substance, Drug product	2020-12-10	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 111 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	N214103-001	ODE-339	2027-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214103-001	ODE-415	2029-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	I-901	2025-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	NCE	2025-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	ODE-339	2027-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214103-001	ODE-415	2029-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214103-001	I-901	2025-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	NCE	2025-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	ODE-339	2027-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214103-001	ODE-415	2029-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214103-001	I-901	2025-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214103-001	NCE	2025-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214103-001	ODE-339	2027-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214103-001	ODE-415	2029-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214103-001	I-901	2025-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214103-001	NCE	2025-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214103-001	ODE-339	2027-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214103-001	ODE-415	2029-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214103-001	I-901	2025-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214103-001	NCE	2025-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214103-001	ODE-339	2027-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214103-001	ODE-415	2029-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214103-001	I-901	2025-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214103-001	NCE	2025-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214103-001	ODE-339	2027-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214103-001	ODE-415	2029-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214103-001	I-901	2025-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214103-001	NCE	2025-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214103-001	ODE-339	2027-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214103-001	ODE-415	2029-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214103-001	I-901	2025-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214103-001	NCE	2025-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214103-001	ODE-339	2027-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214103-001	ODE-415	2029-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214103-001	I-901	2025-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214103-001	NCE	2025-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214103-001	ODE-339	2027-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214103-001	ODE-415	2029-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214103-001	I-901	2025-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214103-001	NCE	2025-11-23	`79d66fd596c7…`

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
OXLUMO	LUMASIRAN	Alnylam Pharmaceuticals, Inc.	16985a31-f5e4-4557-9266-fc78d4bc5055	2025-12-01	Adverse reactions	Exact identifier application applno (NDA): 214103 application number: NDA214103 ndc (product): 71336-1002

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
71336-1002	OXLUMO	lumasiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1002	OXLUMO	lumasiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1002	OXLUMO	lumasiran	Alnylam Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81886	SUPPL	2025-04-08
81832	SUPPL	2025-04-07
75527	SUPPL	2023-09-21
75521	SUPPL	2023-09-20
72281	SUPPL	2022-10-11
72270	SUPPL	2022-10-07
65662	ORIG	2020-12-21
65531	ORIG	2020-12-08
65349	ORIG	2020-11-25